Identity
- Trade Name
- 17-OH-Progesterone ELISA EUDAMEDProgesterone ELISA EUDAMED
- Device Name
- 17-OH-Progesterone ELISA EUDAMEDProgesterone ELISA EUDAMED
- Model / Reference
- RE52071 EUDAMEDRE52231 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049325029781 EUDAMED04049325001824 EUDAMED
- Basic UDI-DI
- 4049325IVR06080001BTF EUDAMEDB-04049325001824 EUDAMED
- Direct Marketing DI
- 04049325029781 EUDAMED
- EMDN Code
- W0102050107 17 OH PROGESTERONE EUDAMEDW0102050106 PROGESTERONE EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
17-OH-Progesterone ELISA by Ibl International Gmbh — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 4049325IVR06080001BTF | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 4049325IVR06080001BTF | Class B | Active |
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Manufacturer
- Manufacturer
- IBL International GmbH
- EUDAMED SRN
- DE-MF-000015709
Sources (2)
- EUDAMED 5e23705d-fc1c-47e1-bc0f-7eda5accd2ea 61 fields · synced Jul 10, 2026
- EUDAMED b1d4b3ea-d989-49a3-9313-6403f5aa30d8 61 fields · synced Jul 10, 2026