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Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence Method)
EUDAMEDClass IVD General (EU MDR)
Ref W-IF-AMH-20Model 20 tests/kitRef W-IF-AMH-40Model 40 tests/kitRef W-IF2-AMH-40Ref W-IF2-AMH-20
Identity
- Trade Name
- Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence Method) EUDAMED
- Device Name
- Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence Method) EUDAMED
- Model / Reference
- 20 tests/kit EUDAMEDW-IF-AMH-20 EUDAMED40 tests/kit EUDAMEDW-IF-AMH-40 EUDAMEDW-IF2-AMH-40 EUDAMEDW-IF2-AMH-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973720131757 EUDAMED06973720131764 EUDAMED06978896415830 EUDAMED06978896415823 EUDAMED
- Basic UDI-DI
- B-06973720131757 EUDAMEDB-06973720131764 EUDAMEDB-06978896415830 EUDAMEDB-06978896415823 EUDAMED
- EMDN Code
- W0102050299 PREGNANCY TESTING HORMONES - OTHER EUDAMEDW0102050215 ANTI-MULLERIAN HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
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-Mullerian Hormone (AMH) Test Kit (Immunofluorescence Method) by Wuhan Easydiagnosis Biomedicine 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-06973720131757 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (4)
- EUDAMED 751c9cfe-0c74-4b44-9580-ab4d4ef5f2dd 61 fields · synced Oct 6, 2026
- EUDAMED cabe2633-bac1-43a8-be3d-4e88a79c3ad8 61 fields · synced May 17, 2026
- EUDAMED c4789e6f-6297-464f-ab96-dce1605f39cf 61 fields · synced May 18, 2026
- EUDAMED 2d780547-d42c-4fc2-9b00-7f465e8fbe08 61 fields · synced May 19, 2026