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Nantong EgensBiotechnology Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000021561

Devices
39
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates
Authorised rep.
SUNGO Europe B.V.NL
Authorised rep.
Shanghai International Holding Corp. GmbH(Europe)DE

Catalogue39

Newest first, rows 1-39 of 39

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Rows 1-39 of 39

Company details

EUDAMED SRN
CN-MF-000021561
EUDAMED status
Active
EUDAMED registered name
Nantong EgensBiotechnology Co.,Ltd.
Registered address
Building 15, Building 12(west), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone,, 226010, Nantong, China
PRRC contact
Yanzi Lu(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredIVDR 2next expiry 22 Oct 2030

EUDAMED certificates (2)

TÜV SÜD Product Service GmbH 0123 2 certificates

  • V13 063367 0022 Active

    Quality management system EU IVDR

    Issued
    25 Jun 2026
    Expires
    24 Jun 2031
  • V76 063367 0026 Active

    Technical documentation EU IVDR

    Issued
    23 Oct 2025
    Expires
    22 Oct 2030

Frequently asked questions

How many devices does Nantong EgensBiotechnology Co.,Ltd. have in the registry?

The registry currently lists 39 devices for Nantong EgensBiotechnology Co.,Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Nantong EgensBiotechnology Co.,Ltd.'s devices?

Among its 39 most recently registered devices, Nantong EgensBiotechnology Co.,Ltd. has devices listed in EUDAMED (39 devices).

What risk classes do Nantong EgensBiotechnology Co.,Ltd.'s devices fall under?

Among its 39 most recently registered devices, the classes recorded for Nantong EgensBiotechnology Co.,Ltd.'s devices are IVD general, IVD Annex II List B and IVD devices for self-testing. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Nantong EgensBiotechnology Co.,Ltd.?

EUDAMED lists 2 certificates for Nantong EgensBiotechnology Co.,Ltd. (quality management system; technical documentation) under IVDR. 2 are recorded with the status issued. The most recent was issued on 25 Jun 2026.

What are the newest devices from Nantong EgensBiotechnology Co.,Ltd. in the registry?

The most recently registered devices listed for Nantong EgensBiotechnology Co.,Ltd. include SEMA PROTECT, Ovulation (LH) Test for Self Testing, Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold) and Multiple Drugs of Abuse Rapid Tests.

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