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Anti-Mullerian Hormone Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3010698Model 100Tests/KitRef 3013744Model 2×50Tests/Kit
Identity
- Trade Name
- Anti-Mullerian Hormone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Anti-Mullerian Hormone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100Tests/Kit EUDAMED3010698 EUDAMED2×50Tests/Kit EUDAMED3013744 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794518675 EUDAMED06942202224188 EUDAMED
- Basic UDI-DI
- B-06925794518675 EUDAMEDB-06942202224188 EUDAMED
- EMDN Code
- W0102050215 ANTI-MULLERIAN HORMONE 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
Anti-Mullerian Hormone 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-06925794518675 | 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 0dad04a9-4857-47e0-9a16-55f66cbdea14 61 fields · synced Oct 6, 2026
- EUDAMED c32e2ff1-3b2b-4ccd-ad9f-a1d62a51b4a0 61 fields · synced May 18, 2026