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
Catalogue
Singclean® Ref HCG10-01-100t
Singclean® Ref LH-01-25t
Singclean® Ref HCG-01-10t
Singclean® Ref HCG10-02-25t
Singclean® Ref HCG-01-50t
Singclean® Ref HCG-03-2t
Singclean® Ref HCG10-03-2t
Singclean® Ref HCG-02-40t
Singclean® Ref LH-02-5t
Earlibird® Ref HCG-EB-03-1tP
Singclean® Ref HCG-01-100t
Singclean® Ref M61-04-20t
Singclean® Ref HCG10-03-20t
Singclean® Ref HCG-01-1t
Singclean® Ref HCG-02-2t
Validcheck® Ref HCG-VC-03-1t
Singclean® Ref HCG-03-20t
Singclean® Ref HCG-03-1t
Pretthyal® Ref DF-PH4-20-2.0
Singclean® Ref HCG10-01-1t
Singclean® Ref HCG10-02-5t
Singclean® Ref LH-01-100t
Pepino® Ref HCG10-PP-01-2t
Singclean® Ref LH-03-20t
Singclean Ref IVD49-02-40t
Earlibird® Ref HCG-EB-03-1tB
Pretthyal® Ref DF-PH2-20-2.0
Pretthyal® Ref DF-PH2-20-1.0
Singclean® Ref HCG10-01-10t
Pretthyal® Ref DF-PH3-20-2.0
Singclean® Ref M61-02-25t
Singclean® Ref HCG-02-25t
Singclean® Ref HCG10-01-25t
Surgiclean® Ref MPH-SG-5.0
Surgiclean® Ref MPH-SG-1.0
Surgiclean® Ref MPH-SG-2.0
Surgiclean® Ref MPH-SG-0.5
Singclean® Ref MDMA-05-25t
Quickclean® Ref MPH-QC-2.0
Singfiller Ref DF-SF3-20-1.0
Singclean Ref IVD108-02-05t
Singclean Ref DOA-02-25t
Singclean® Ref MPV-02-01t
Singclean Ref IVD107-02-10t
Singfiller Ref DF-SF2-20-2.0
Singclean® Ref OXY-05-25t
Singclean Ref IVD109-02-20t
singclean Ref MDOA-05-25t
Singfiller Ref DF-SF4-20-1.5
Surgiclean® Ref ORC-SG-5×25
Showing 1-50 of 293
EUDAMED certificates
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
Related companies
Authorised representatives
Notified bodies
- Notified body 2797
- Notified body 2292
- TÜV SÜD Product Service GmbH 0123
- DNV Product Assurance AS 2460
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.
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.
Information
- Country
- China
- Address
- No. 125(E), 10th Street, Hangzhou, China
- Website
- www.singclean.net
- facebook.com/singclean
- [email protected]
- PRRC contact
- Jiaqi Hu
- EUDAMED SRN
- CN-MF-000014098