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17-Alpha-Hydoxy Progesterone (17Alpha-OHP) Assay Kit (Chemiluminescent Immunoas…

EUDAMED

Class IVD General (EU MDR)

Ref 25 Tests/KitRef 100 Tests/KitRef 50 Tests/KitModel 50 Tests/Kit

by Wuhan Life Origin Biotech Joint Stock Co., Ltd.

Identity

Trade Name
17-Alpha-Hydoxy Progesterone (17Alpha-OHP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Device Name
17-Alpha-Hydoxy Progesterone (17Alpha-OHP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Model / Reference
25 Tests/Kit EUDAMED
100 Tests/Kit EUDAMED
50 Tests/Kit EUDAMED

Identifiers

Primary DI / UDI-DI
06974986815108 EUDAMED
06974986815122 EUDAMED
06974986815115 EUDAMED
Basic UDI-DI
B-06974986815108 EUDAMED
B-06974986815122 EUDAMED
B-06974986815115 EUDAMED
EMDN Code
W0102050107 17 OH PROGESTERONE EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

17-Alpha-Hydoxy Progesterone (17Alpha-OHP) Assay Kit (Chemiluminescent Immunoas… by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
EUDAMED SRN
CN-MF-000027340
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED ecb35e85-1659-4f91-b2ef-f52af2ec4cfe 61 fields · synced Oct 6, 2026
  • EUDAMED 15e2b588-fe15-4105-811c-239c105037b6 61 fields · synced May 17, 2026
  • EUDAMED 867e9b84-bc3e-4898-933b-c5382982c29a 61 fields · synced May 18, 2026