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Hangzhou Singclean Medical Products Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000014098

Devices
315
Registrations
EUDAMED

What Hangzhou Singclean Medical Products Co., Ltd. makes

Hangzhou Singclean Medical Products Co., Ltd. manufactures a range of medical devices including single-use surgical instruments like forceps, retractors, and suction tools under brands such as Singclean® and Quickclean®. Their portfolio also includes medical-grade filling systems (Singfiller) and single-use surgical drapes and gowns (enAvant). Some products are designed for reusable processing in healthcare settings, while others are intended for single-patient use.

The company’s devices are classified under EU regulations as Class IIa, IIb, and III medical devices, with some listed as in vitro diagnostics (IVDs) for general use and self-testing. These products are registered in the EU’s eudamed database, adhering to regulatory requirements for medical device compliance. The manufacturer is based in China.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue315

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  • Singclean® Ref IVD46-02-20t

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Singclean® Ref IVD64-02-20t

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Singclean® Ref MTD-05-25t

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Surgiclean® Ref ORC-SG-3×5

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • Singclean® Ref NGAL-02-50t

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • enAvant Ref DF-EA2-20-1.5

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Singclean® Ref IVD49-02-50t

    Active Regimes: CE IVDR CE IVDD Registry: EUDAMED Class:IVD General

  • Singclean Ref IVD110-02-20t

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Singclean® Ref MOP-02-25t

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Quickclean Ref ORT-QC-12-1.0

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Singclean Ref THC-02-25t

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Quickclean Ref ORT-QC-20-3.0

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Singclean® Ref PCP-05-25t

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Singclean Ref DOA-02-5t

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Singclean Ref SP-02-5t

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

Rows 301-315 of 315

Showing 301-315 of 315

Company details

EUDAMED SRN
CN-MF-000014098
EU VAT number
91330101747181911R
EUDAMED status
Active since 2019
EUDAMED registered name
Hangzhou Singclean Medical Products Co., Ltd.
EUDAMED abbreviated name
Hangzhou Singclean
Registered address
No. 125(E), 10th Street, 310018, Hangzhou, China
PRRC contact
Jiaqi Hu(public in EUDAMED)

EUDAMED certificates12

12 certificates12 valid, 0 expiredIVDR 6, MDR 6next expiry 17 Apr 2028

EUDAMED certificates (12)

DNV Product Assurance AS 2460 4 certificates

  • C544401 Active

    Quality management system EU MDR

    Issued
    30 Dec 2024
    Expires
    29 Dec 2029
  • C544578 Active

    Technical documentation EU MDR

    Issued
    3 Dec 2024
    Expires
    2 Dec 2029
  • C637543 Active

    Quality management system EU MDR

    Issued
    3 Dec 2024
    Expires
    2 Dec 2029
  • 10000471388-PA-NoMA-CHN Active

    Quality management system EU MDR

    Issued
    17 Apr 2023
    Expires
    17 Apr 2028

BSI Group The Netherlands B.V. 2797 3 certificates

  • IVDR 823882 Active

    Technical documentation EU IVDR

    Issued
    17 Aug 2026
    Expires
    16 Aug 2031
  • IVDR 823886 Active

    Technical documentation EU IVDR

    Issued
    17 Aug 2026
    Expires
    16 Aug 2031
  • IVDR 823878 Active Supplemented

    Quality management system EU IVDR

    Issued
    17 Aug 2026
    Expires
    30 Nov 2030
    Reason
    Add device or group

TÜV SÜD Product Service GmbH 0123 3 certificates

  • V74 097027 0010 Active

    Technical documentation EU IVDR

    Issued
    28 Apr 2025
    Expires
    27 Apr 2030
  • V13 097027 0013 Active

    Quality management system EU IVDR

    Issued
    10 Jun 2026
    Expires
    23 Apr 2029
  • V74 097027 0007 Active Supplemented

    Technical documentation EU IVDR

    Issued
    20 Jan 2025
    Expires
    1 Apr 2029
    Reason
    Add device or group

UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292 2 certificates

  • MDR.2292-2026/0023 Active

    Quality management system EU MDR

    Issued
    15 May 2026
    Expires
    14 May 2031
  • MDR.2292-2026/0024 Active

    Technical documentation EU MDR

    Issued
    15 May 2026
    Expires
    14 May 2031