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17α-Hydroxyprogesterone Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013741Model 2×50Tests/KitRef 3010667Model 50Tests/Kit
Identity
- Trade Name
- 17α-Hydroxyprogesterone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- 17α-Hydroxyprogesterone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50Tests/Kit EUDAMED3013741 EUDAMED50Tests/Kit EUDAMED3010667 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202224157 EUDAMED06925794518286 EUDAMED
- Basic UDI-DI
- B-06942202224157 EUDAMEDB-06925794518286 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
Yes
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
17α-Hydroxyprogesterone Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06942202224157 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c6be5fc5-974f-498d-b234-2e3fc77de83f 61 fields · synced Jul 27, 2026
- EUDAMED a5e7d8ed-348d-4bc7-98f9-b3833407f415 61 fields · synced May 18, 2026