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Anti-Müllerian Hormone (EECL)
EUDAMEDClass IVD General (EU MDR)
Ref 1030312000Model 100 tests/kitRef 1030301000Model 25 tests/kitRef 1030311000Model 50 tests/kit
Identity
- Device Name
- Anti-Müllerian Hormone (EECL) EUDAMED
- Model / Reference
- 100 tests/kit EUDAMED1030312000 EUDAMED25 tests/kit EUDAMED1030301000 EUDAMED50 tests/kit EUDAMED1030311000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975090503349 EUDAMED06975090500348 EUDAMED06975090502342 EUDAMED
- Basic UDI-DI
- B-06975090503349 EUDAMEDB-06975090500348 EUDAMEDB-06975090502342 EUDAMED
- EMDN Code
- W0102050215 ANTI-MULLERIAN HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Anti-Müllerian Hormone (EECL) by Accucise Diagnostics Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975090503349 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Accucise Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000045017
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED 728dee92-2dea-4e46-88ec-ad8d8c2ca267 61 fields · synced Jul 12, 2026
- EUDAMED 02e3cc6f-4552-4260-87e4-9baefc18f62e 61 fields · synced May 17, 2026
- EUDAMED 468a1d87-17a0-4995-b710-1ce4b46e603c 61 fields · synced May 18, 2026