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Hangzhou Singclean Medical Products Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000014098

Devices
315
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

12 of 12 in force.

See certificates

Market reach

European Union
EUDAMED actor, 12 certificates
Authorised rep.
Hangzhou Singclean Medical Products Filial SwedenSE
Authorised rep.
Obelis S.A.BE
Authorised rep.
SUNGO Europe B.V.NL

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

Newest first, rows 1-50 of 315

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  • Singclean® Ref COC-05-25t

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

  • Singclean® Ref M90-02-25t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG-02-5t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Earlibird® Ref HCG10-EB-03-1tP

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Surgiclean® Ref MPH-SG-3.0

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Singclean® Ref HCG-02-10t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG-03-5t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref LH-01-1t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG-01-25t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref M90-04-20t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Pretthyal® Ref DF-PH4-20-1.0

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Singclean® Ref HCG-02-1t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG10-01-5t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG10-03-5t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Pretthyal® Ref DF-PH3-20-1.0

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Singclean® Ref HCG10-02-50t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean Ref IVD49-02-25t

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Singclean® Ref HCG10-02-40t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG10-02-10t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref LH-02-50t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref LH-02-1t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref LH-02-25t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref M61-05-25t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG10-02-1t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref LH-01-50t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG10-03-1t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Earlibird® Ref HCG10-EB-03-1tB

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG10-02-2t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref LH-03-1t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref LH-01-5t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Pepino® Ref HCG10-PP-03-1t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref M90-05-25t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Pretthyal® Ref DF-PH1-20-1.0

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Singclean® Ref HCG-01-5t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG-02-50t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref LH-02-40t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG10-01-50t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean Ref IVD49-02-10t

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Singclean® Ref HCG10-01-100t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref LH-01-25t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG-01-10t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG10-02-25t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG-01-50t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG-03-2t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG10-03-2t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG-02-40t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref LH-02-5t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Earlibird® Ref HCG-EB-03-1tP

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref HCG-01-100t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Singclean® Ref M61-04-20t

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

Rows 1-50 of 315

Showing 1-50 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

Frequently asked questions

How many devices does Hangzhou Singclean Medical Products Co., Ltd. have in the registry?

The registry currently lists 315 devices for Hangzhou Singclean Medical Products Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

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

Among its 50 most recently registered devices, Hangzhou Singclean Medical Products Co., Ltd. has devices listed in EUDAMED (50 devices).

What risk classes do Hangzhou Singclean Medical Products Co., Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Hangzhou Singclean Medical Products Co., Ltd.'s devices are Class III, IVDR Class B, IVDR Class C and IVD general. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Hangzhou Singclean Medical Products Co., Ltd.?

EUDAMED lists 12 certificates for Hangzhou Singclean Medical Products Co., Ltd. (technical documentation; quality management system) under MDR and IVDR. 10 are recorded with the status issued. The most recent was issued on 17 Aug 2026.

What are the newest devices from Hangzhou Singclean Medical Products Co., Ltd. in the registry?

The most recently registered devices listed for Hangzhou Singclean Medical Products Co., Ltd. include Singclean®, Earlibird®, Surgiclean® and Pretthyal®.

Generated automatically from registry data and not verified by a human reviewer.