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Assure Tech. (Hangzhou) Co., Ltd.

Active in EUDAMED

Country not established EUDAMED FDA SRN CN-MF-000002170

Part of Assure Tech. (Hangzhou) Co., Ltd.

Devices
292
Registrations
EUDAMEDFDA
FDA recalls
0

Catalogue292

Newest first, rows 251-292 of 292

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Rows 251-292 of 292

Showing 251-292 of 292

Company details

EUDAMED SRN
CN-MF-000002170
DUNS number
530757741
EU VAT number
913301066767726252
EUDAMED status
Active
EUDAMED registered name
Assure Tech. (Hangzhou) Co., Ltd.
Registered address
Moganshan Road, Gongshu District, Building 4, No. 1418-50, 310011, Hangzhou, Zhejiang, China
Phone
+(86)571-81022698
PRRC contact
Allen Chen(public in EUDAMED)

EUDAMED certificates6

6 certificates6 valid, 0 expiredIVDR 6next expiry 12 Jun 2029

EUDAMED certificates (6)

TÜV Rheinland LGA Products GmbH 0197 5 certificates

  • IX 2074650-2 Active

    Technical documentation EU IVDR

    Issued
    17 Mar 2026
    Expires
    16 Mar 2031
  • IX 2074650-3 Active

    Technical documentation EU IVDR

    Issued
    17 Mar 2026
    Expires
    16 Mar 2031
  • IX 2074650-4 Active

    Technical documentation EU IVDR

    Issued
    17 Mar 2026
    Expires
    16 Mar 2031
  • HX 2074650-1 Active Supplemented

    Quality management system EU IVDR

    Issued
    17 Mar 2026
    Expires
    12 Jun 2029
    Reason
    Add device or group
  • IX 2074650-1 Active

    Technical documentation EU IVDR

    Issued
    27 Dec 2024
    Expires
    12 Jun 2029

DEKRA Certification B.V. 0344 1 certificate

  • 2279233CE01 Active Supplemented

    Quality management system EU IVDR

    Issued
    10 Sep 2024
    Expires
    1 Sep 2029
    Reason
    Add device or group

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Assure Tech. (Hangzhou) Co., Ltd. Hangzhou Zhejiang · CN FEI 3038560224

Frequently asked questions

How many devices does Assure Tech. (Hangzhou) Co., Ltd. have in the registry?

The registry currently lists 292 devices for Assure Tech. (Hangzhou) Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

What EUDAMED certificates are recorded for Assure Tech. (Hangzhou) Co., Ltd.?

EUDAMED lists 6 certificates for Assure Tech. (Hangzhou) Co., Ltd. (technical documentation; quality management system) under IVDR. 4 are recorded with the status issued. The most recent was issued on 17 Mar 2026.

Which FDA establishments are linked to Assure Tech. (Hangzhou) Co., Ltd.?

1 FDA establishment is linked to Assure Tech. (Hangzhou) Co., Ltd. in the registry; they are listed on the company page.

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