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Review current management-system certificates, market registrations and clearly labeled historical records, now organized by destination market and jurisdiction.
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Browse every current certificate, registration and clearly labeled historical record by destination market.
39 records
CHINA CUSTOMS CURRENT DOCUMENTAEO Certified Enterprise三奇AEO认证企业证书（海关认证）+
China Customs Authorized Economic Operator (AEO) certificate issued by Qingdao Customs, recognizing Sanqi as an advanced certified enterprise.
- Certificate No.
- 168371999001
- AEO Code
- AEOCN3711963074
- Enterprise type
- Advanced certified enterprise
- Date of authorization
- 2021-07-22
- Issuing authority
- Qingdao Customs, People's Republic of China
UNITED STATES HISTORICAL RECORDFDA Establishment Registration RecordDated company registration evidence+
The supplied 2021 screenshot records Sanqi's FDA establishment information. It is retained as historical evidence and does not confirm current registration status.
- Registration
- 3010374972
- Owner/operator
- 10044543
- Record date
- 2021 screenshot
- Current check
- Verify directly against the current FDA database before use.
FDA 510(k) HISTORICAL RECORDFDA 510(k) Database Record - K093901Surgical face mask database listing+
The supplied FDA database screenshot references premarket submission K093901 for a surgical face mask. It is presented as a dated database record rather than a current clearance letter.
- Submission
- K093901
- Product code
- FXX
- Device class
- Class II
- Regulation
- 21 CFR 878.4040
- Record date
- 2020 screenshot
UNITED STATES / WRAP CURRENT DOCUMENTWRAP Gold Certificate of ComplianceFacility social-responsibility and production compliance+
Worldwide Responsible Accredited Production (WRAP) certifies the listed Sanqi facility at Gold level for the production processes stated in the certificate. WRAP is headquartered in Arlington, Virginia, USA, while this certificate applies to the Rizhao production facility.
- Certificate No.
- 131940
- Level
- Gold
- Validity
- 2026-02-13 to 2027-02-13
- Sample size
- 20
- Production processes
- Cutting, heat sealing, sewing, inspection, testing and packing
- Issuing program
- Worldwide Responsible Accredited Production (WRAP)
EU PPE CURRENT DOCUMENTCE 758275FFP1, FFP2 and FFP3 filtering half masks+
BSI completed the EU type-examination procedure for listed filtering half masks under PPE Regulation (EU) 2016/425, Module B.
- Issuer
- BSI Group The Netherlands B.V.
- Notified body
- 2797
- Standard
- EN 149:2001+A1:2009
- Validity
- 2024-01-03 to 2029-01-02
MANAGEMENT SYSTEM CURRENT DOCUMENTISO 9001:2015Quality management system+
TÜV Rheinland certifies Sanqi's quality management system for the manufacture and sale of medical hygiene materials and dressings.
- Registration
- 01 100 1632995
- CNCA
- F00526Q00078R317
- Issuer
- TÜV Rheinland
- Validity
- 2026-01-20 to 2029-01-19
MEDICAL DEVICE QMS CURRENT DOCUMENTEN ISO 13485:2016Medical-device quality management system+
The certified scope covers design, manufacture and distribution of listed medical devices, plus ethylene oxide sterilization service under EN ISO 11135:2014.
- Registration
- SX 2074202-1
- Issuer
- TÜV Rheinland LGA Products GmbH
- Standard
- EN ISO 13485:2016 + AC:2018 + A11:2021
- Validity
- 2026-02-28 to 2029-02-27
GWPCEU PPE SUPPLIED DOCUMENTCE 1166190978-01-02Chemical protective coverall - GWPC+
EU type-examination certificate supplied for the GWPC chemical protective coverall under Regulation (EU) 2016/425.
- Issuer
- Centro Tessile Cotoniero e Abbigliamento
- Notified body
- 0624
- Model
- GWPC
- Category
- III
- Use note
- Confirm current validity for the requested product and market.
SCPCEU PPE SUPPLIED DOCUMENTCE 1166200055-01-00Chemical protective coverall - SCPC+
EU type-examination certificate supplied for the SCPC chemical protective coverall under Regulation (EU) 2016/425.
- Issuer
- Centro Tessile Cotoniero e Abbigliamento
- Notified body
- 0624
- Model
- SCPC
- Category
- III
- Use note
- Confirm current validity for the requested product and market.
EU PPE SUPPLIED DOCUMENTCE 1166200053-00-00Chemical protective clothing set - SSPC+
EU type-examination certificate supplied for the SSPC chemical protective clothing set under Regulation (EU) 2016/425.
- Issuer
- Centro Tessile Cotoniero e Abbigliamento
- Notified body
- 0624
- Model
- SSPC
- Category
- III
- Use note
- Confirm current validity for the requested product and market.
N95NIOSH RESPIRATORY PROTECTION APPROVAL & TEST EVIDENCEN95 / NIOSH Approval and Test EvidenceRespirator approval letters and current supplied test reports+
The supplied file set includes NIOSH approval letters for multiple Sanqi N95 and Surgical N95 configurations, together with 2025 Evaluation and Testing Branch reports for the SQ100D and SQ100G programs.
- Approval models
- SQ100Cb, SQ100CVb, SQ100Sb, SQ100Vb, SQ100Sc and SQ100Gs
- 2025 test models
- SQ100D / SQ100G
- Authority
- NIOSH NPPTL
- Tests
- Exhalation resistance, inhalation resistance and sodium chloride (NaCl) aerosol testing for N95 performance
L1MEDICAL MASK PERFORMANCE TEST EVIDENCEASTM F2100 Level 1 Test EvidenceSQ1001 medical mask+
Representative supplied performance report for the SQ1001 medical-mask program, covering bacterial filtration efficiency and differential pressure.
- Model
- SQ1001
- Standard
- ASTM F2100 / EN 14683
- Length
- 13 pages
- Language
- English
L2MEDICAL MASK PERFORMANCE TEST EVIDENCEASTM F2100 Level 2 Test EvidenceSQ2001 medical mask+
Representative supplied performance report for the SQ2001 medical-mask program, covering bacterial filtration efficiency and differential pressure.
- Model
- SQ2001
- Standard
- ASTM F2100 / EN 14683
- Report
- 1291212-S02
- Length
- 13 pages
L3MEDICAL MASK PERFORMANCE TEST EVIDENCEASTM F2100 Level 3 Test EvidenceSQ3001 medical mask+
Representative supplied performance report for the SQ3001 medical-mask program, covering bacterial filtration efficiency and differential pressure.
- Model
- SQ3001
- Standard
- ASTM F2100 / EN 14683
- Report
- 1291212-S04
- Length
- 13 pages
IIREU MEDICAL MASK PERFORMANCE TEST EVIDENCEEN 14683 Type IIR Test EvidenceSurgical mask with splash-resistance assessment+
Supplied test report for a Type IIR surgical mask covering bacterial filtration efficiency, microbial cleanliness, differential pressure and splash resistance.
- Report
- 20R002113
- Standard
- EN 14683:2019+AC:2019
- Issuer
- GTTC
- Date
- 2020-05-28
IIEU MEDICAL MASK PERFORMANCE TEST EVIDENCEEN 14683 Type II Test EvidenceMedical face mask performance report+
Supplied SGS test report for a Type II medical face mask, retained as product-level performance evidence.
- Report
- SL52035299246501TX
- Standard
- EN 14683
- Issuer
- SGS Shanghai
- Date
- 2020-09-28
IEU MEDICAL MASK PERFORMANCE TEST EVIDENCEEN 14683 Type I Test EvidenceMedical face mask performance report+
Supplied SGS test report for a Type I medical face mask, retained as product-level performance evidence.
- Report
- SL52035299246101TX
- Standard
- EN 14683
- Issuer
- SGS Shanghai
- Date
- 2020-09-28
STERILIZATION SERVICE CERTIFIED SCOPEEN ISO 11135:2014 Sterilization ScopeEthylene oxide sterilization for single-use medical devices+
This is a certified scope within the EN ISO 13485 certificate: provision of ethylene oxide sterilization service for single-use medical devices in accordance with EN ISO 11135:2014.
- Certificate
- EN ISO 13485:2016
- Registration
- SX 2074202-1
- Scope standard
- EN ISO 11135:2014
- Validity
- 2026-02-28 to 2029-02-27
CCQSEU PPE HISTORICAL RECORDArchived CCQS certificatesExpired Module B and Module C2 records+
These supplied CCQS documents relate to model 3Q1C3S and are archived because their stated validity periods have ended.
- Module B
- CE-PC-200310-034-01-9B - expired 2025-08-04
- Module C2
- CE-PC-200310-034-FPC-B - expired 2023-08-04
- Status
- Not presented as current market authorization
AUSTRALIA REGISTRATION RECORDARTG 389571Single-use surgical / medical respirator+
The supplied ARTG certificate covers a single-use surgical or medical respirator intended for aerosol filtration and fluid-penetration resistance.
- Start date
- 2022-06-03
- Class
- Medical Device Included Class 1
- Sponsor
- Wiselink Group Pty Ltd
- Manufacturer
- Rizhao Sanqi Medical & Health Articles Co., Ltd.
AUSTRALIA REGISTRATION RECORDARTG 383369Single-use isolation gown+
The supplied ARTG certificate covers a non-sterile single-use isolation gown for protection against infective agents, particles and non-hazardous liquid splasheses.
- Start date
- 2022-02-02
- Class
- Medical Device Included Class 1
- Sponsor
- Wiselink Group Pty Ltd
- Manufacturer
- Rizhao Sanqi Medical & Health Articles Co., Ltd.
ARTGAUSTRALIA REGISTRATION RECORDARTG 383370Single-use operating-room gown+
The supplied ARTG certificate covers a disposable operating-room gown used during surgical procedures.
- Start date
- 2022-02-02
- Class
- Medical Device Included Class 1
- Sponsor
- Wiselink Group Pty Ltd
- Manufacturer
- Rizhao Sanqi Medical & Health Articles Co., Ltd.
ARTGAUSTRALIA REGISTRATION RECORDARTG 383371Face shield+
The supplied ARTG certificate covers a transparent face shield intended to protect healthcare workers from blood and body-fluid splashes.
- Start date
- 2022-02-02
- Class
- Medical Device Included Class 1
- Sponsor
- Wiselink Group Pty Ltd
- Manufacturer
- Rizhao Sanqi Medical & Health Articles Co., Ltd.
ARTGAUSTRALIA REGISTRATION RECORDARTG 383372Protective eye shield / goggles+
The supplied ARTG certificate covers non-sterile protective goggles intended to shield healthcare workers from blood and body-fluid splashes.
- Start date
- 2022-02-02
- Class
- Medical Device Included Class 1
- Sponsor
- Wiselink Group Pty Ltd
- Manufacturer
- Rizhao Sanqi Medical & Health Articles Co., Ltd.
FDAUNITED STATES FY2026 LISTING NOTICEFDA FY2026 Registration and Device ListingEstablishment registration and listed product families+
The supplied FY2026 notice records Sanqi's FDA establishment registration and device listings. Registration and listing do not by themselves denote FDA approval; buyers should verify the live database before use.
- Registration
- 3010374972
- Owner/operator
- 10044543
- Fiscal year
- 2026
- Listed records include
- K093901, K202903, Surgical N95, gowns, shields and other medical supplies
510KFDA 510(k) SUPPLIED SUMMARYFDA 510(k) Summary - K202903Surgical face masks, Levels 1, 2 and 3+
The supplied 510(k) summary identifies Sanqi surgical face-mask models and performance levels associated with K202903. It is presented as a supplied summary and should be verified against the FDA database.
- Submission
- K202903
- Product code
- FXX
- Device class
- Class II
- Models
- SQ-1001, SQ-2001 / 2001H, SQ-2004 / 2004H, SQ-3001 / 3001H
- Summary date
- 2021-12-24
F2100MEDICAL MASK PERFORMANCE 2026 TEST EVIDENCEASTM F2100-25 Medical Mask ReportsK202903 Level 1, Level 2, Level 3 and PFE evidence+
Four supplied 2026 reports cover ASTM F2100-25 performance testing for the K202903 medical-mask family, including the three performance levels and a supplementary particulate-filtration report.
- Issuer
- Shanghai SUNGO Medical Technology Co., Ltd.
- Report series
- SGT-202602001-01 / -02 / -03 / -07
- Report dates
- 2026-03-04 to 2026-03-12
- Models
- SQ1001, SQ2001 and SQ-3001
PB70ISOLATION GOWN PERFORMANCE TEST EVIDENCEAAMI PB70 Isolation Gown Report SetLevel 1, Level 2, Level 3 and supporting material tests+
The supplied report set covers isolation-gown liquid-barrier levels and supporting material-performance testing across several Sanqi constructions and model configurations.
- Standards
- ANSI/AAMI PB70:2012 and PB70:2022; supporting ASTM material methods
- Models include
- D010, SQ-I2001, SQ-I2001Y and SQ-I3001B
- Issuers
- SGS and Intertek
- Report years
- 2020, 2021, 2023 and 2024
AAMISURGICAL GOWN PERFORMANCE TEST EVIDENCEAAMI PB70 Surgical Gown ReportsLevel 2 and Level 3 liquid-barrier evidence+
The supplied SGS reports cover liquid-barrier testing for Sanqi surgical-gown models SQ-G2001 and SQ-G3001.
- Standard
- ANSI/AAMI PB70:2012
- Models
- SQ-G2001 / SQ-G3001
- Levels
- Level 2 / Level 3
- Report dates
- 2020-10-26 / 2021-07-14
MOD DEU PPE CURRENT DOCUMENTCE 758276 - Module DRespiratory-protection production quality assurance+
BSI certifies conformity to type based on quality assurance of the production process for Sanqi respiratory protective equipment under PPE Regulation (EU) 2016/425, Annex VIII Module D.
- Issuer
- BSI Group The Netherlands B.V.
- Notified body
- 2797
- Certificate
- CE 758276
- Validity
- 2024-01-03 to 2029-01-02
SRNEU MDR / EUDAMED DATABASE RECORDEUDAMED Economic Operator RecordManufacturer SRN CN-MF-000008918+
The supplied EUDAMED screenshot identifies Rizhao Sanqi Medical & Health Articles Co., Ltd. as a manufacturer. It is a dated database record and should be checked against the live EUDAMED entry.
- Actor ID / SRN
- CN-MF-000008918
- Role
- Manufacturer
- Country
- China
- Record update shown
- 2021-06-30
DoCEU MDR SUPPLIED DECLARATIONSEU MDR Declaration PortfolioNine product-family Declarations of Conformity+
The supplied signed declaration portfolio covers face masks, gowns, medical gloves, face shields and underpads. Each declaration must be matched to the exact product, intended use and current regulatory route.
- Document type
- Manufacturer Declarations of Conformity
- Product families
- 9
- Market framework
- European Union medical devices
- Use note
- Verify current signed revision for the requested model.
14683EU MEDICAL MASK PERFORMANCE 2026 TEST EVIDENCEEN 14683:2025 Medical Mask ReportsType I, Type II and Type IIR performance evidence+
13795EU SURGICAL GOWN PERFORMANCE TEST EVIDENCEEN 13795-1 Surgical Gown ReportSQ-G5001 standard-performance surgical gown+
The supplied SGS report records that the tested SQ-G5001 surgical gown met the listed EN 13795-1:2019 standard-performance requirements.
- Report
- SL52035309792201TX
- Model
- SQ-G5001
- Standard
- EN 13795-1:2019
- Date
- 2020-11-10
LSPCEU PPE SUPPLIED DOCUMENTCE 1166230031-00-00Chemical protective clothing set - LSPC / LCPC+
EU type-examination certificate supplied for the LSPC chemical protective clothing set and listed LSPC / LCPC variations under Regulation (EU) 2016/425.
- Issuer
- Centro Tessile Cotoniero e Abbigliamento
- Notified body
- 0624
- Model family
- LSPC / LCPC
- Category
- III
SSPCEU PPE SUPPLIED DOCUMENT SETSSPC Chemical Protective Clothing CertificatesSix 2025 EU type-examination records+
The supplied 2025 certificate set covers SSPC coveralls, sleeve covers and boot covers with bound or serged seams under Regulation (EU) 2016/425.
- Issuer
- Centro Tessile Cotoniero e Abbigliamento
- Notified body
- 0624
- Models
- SSPC-C, SSPC/SS-C, SSPC-B, SSPC/SS-B, SSPC-S and SSPC-SS-S
- Category
- III
ARTGAUSTRALIA REGISTRATION RECORDARTG 391674Single-use surgical face mask+
The supplied ARTG public summary records a Class 1 single-use surgical mask entry manufactured by Rizhao Sanqi Medical & Health Articles Co., Ltd.
- Start date
- 2022-07-01
- Class
- Medical Device Included Class 1
- Status shown
- Active
- Sponsor
- Wiselink Group Pty Ltd
DS2JAPAN RESPIRATORY PROTECTION CURRENT DOCUMENTJapan DS2 Type-Examination CertificateSQ100G disposable particulate respirator+
The supplied Japanese type-examination certificate covers the SQ100G disposable half-mask particulate respirator in the DS2 classification.
- Certificate No.
- TM835
- Model
- SQ100G
- Classification
- DS2
- Validity
- 2024-06-27 to 2029-06-26
- Examining body
- Technology Institution of Industrial Safety (Japan)
BUSINESS VERIFICATION CURRENT DOCUMENTD-U-N-S Registered® CompanyDun & Bradstreet company verification record+
The supplied Dun & Bradstreet certificate identifies Rizhao Sanqi Medical & Health Articles Co., Ltd. as a D-U-N-S Registered company for the stated validity period.
- D-U-N-S Number
- 54-817-7072
- Validity
- 2026-05 to 2027-05
- Program
- D-U-N-S Registered
- Verification provider
- Dun & Bradstreet
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