Question 1

How many devices does NewScen Coast Bio-Pharmaceutical Co.,Ltd. have in the registry?

Accepted Answer

The registry currently lists 6 devices for NewScen Coast Bio-Pharmaceutical Co.,Ltd.. Devices recorded under merged duplicate company entries are counted once.

Question 2

Which registries list NewScen Coast Bio-Pharmaceutical Co.,Ltd.'s devices?

Accepted Answer

Among its 6 most recently registered devices, NewScen Coast Bio-Pharmaceutical Co.,Ltd. has devices listed in EUDAMED (6 devices).

Question 3

What risk classes do NewScen Coast Bio-Pharmaceutical Co.,Ltd.'s devices fall under?

Accepted Answer

Among its 6 most recently registered devices, the classes recorded for NewScen Coast Bio-Pharmaceutical Co.,Ltd.'s devices are IVDR Class D and IVD devices for self-testing. Each device page shows its own class and authorisation.

Question 4

What EUDAMED certificates are recorded for NewScen Coast Bio-Pharmaceutical Co.,Ltd.?

Accepted Answer

EUDAMED lists 2 certificates for NewScen Coast Bio-Pharmaceutical Co.,Ltd. (quality management system; technical documentation) under IVDR. 2 are recorded with the status issued. The most recent was issued on 2025-08-08.

Question 5

What are the newest devices from NewScen Coast Bio-Pharmaceutical Co.,Ltd. in the registry?

Accepted Answer

The most recently registered devices listed for NewScen Coast Bio-Pharmaceutical Co.,Ltd. include HIV (1+2) Antibody Rapid Test and Serum Ferritin Test Kit (SF).

NewScen Coast Bio-Pharmaceutical Co.,Ltd.

Catalogue6

HIV (1+2) Antibody Rapid Test Ref HIV3-29204017000

HIV (1+2) Antibody Rapid Test Ref HIV3-29200111000

HIV (1+2) Antibody Rapid Test Ref HIV3-29202511000

HIV (1+2) Antibody Rapid Test Ref HIV3-29200201000

HIV (1+2) Antibody Rapid Test Ref HIV3-29200501000

Serum Ferritin Test Kit (SF) Ref SF-B-29300104000

EUDAMED certificates2

TÜV SÜD Product Service GmbH 0123 2 certificates

Notified bodies

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