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Hangzhou Singclean Medical Products Co., Ltd.

China CN-MF-000014098 Last updated 21 Oct 2026

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Devices
293
Registries
EUDAMED
FDA recalls
0

Catalogue293

Page 1 of 6

Showing 1-50 of 293

EUDAMED certificates12

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (12)

DNV Product Assurance AS 2460 4 certificates

  • C544401 Issued

    Quality management system EU MDR

    Issued
    30 Dec 2024
    Expires
    29 Dec 2029
  • C544578 Issued

    Technical documentation EU MDR

    Issued
    3 Dec 2024
    Expires
    2 Dec 2029
  • C637543 Issued

    Quality management system EU MDR

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

    Quality management system EU MDR

    Issued
    17 Apr 2023
    Expires
    17 Apr 2028

Notified body 2797 3 certificates

  • IVDR 823882 Issued

    Technical documentation EU IVDR

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

    Technical documentation EU IVDR

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

    Technical documentation EU IVDR

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

    Quality management system EU IVDR

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

    Technical documentation EU IVDR

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

Notified body 2292 2 certificates

  • MDR.2292-2026/0023 Issued

    Quality management system EU MDR

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

    Technical documentation EU MDR

    Issued
    15 May 2026
    Expires
    14 May 2031

Notified bodies

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Hangzhou Singclean Medical Products Co., Ltd. manufacture?

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

Where is Hangzhou Singclean Medical Products Co., Ltd. based?

The company is headquartered in Hangzhou, China. This location serves as its primary operational base for manufacturing and distributing its medical device products globally.

Which regulatory registries list Hangzhou Singclean Medical Products Co., Ltd.’s devices?

Hangzhou Singclean Medical Products Co., Ltd.’s devices are listed in the eudamed database, which is the European Union’s centralised registry for medical devices. This registration ensures compliance with EU regulatory requirements for device traceability and transparency.

How are Hangzhou Singclean Medical Products Co., Ltd.’s devices classified under EU regulations?

Under EU regulations, Hangzhou Singclean Medical Products Co., Ltd.’s devices fall into multiple risk-based classifications: Class IIa, Class IIb, and Class III for active or high-risk medical devices. Additionally, some of their products are classified as in vitro diagnostics (IVDs), including those for general use and self-testing, reflecting their diverse range of applications in healthcare settings.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
China
Address
No. 125(E), 10th Street, Hangzhou, China
PRRC contact
Jiaqi Hu
EUDAMED SRN
CN-MF-000014098