← Back to catalogue
Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref 52026117Model 25T/kitRef 52027112Model 50T/kit
Identity
- Trade Name
- Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence) EUDAMED
- Device Name
- Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence) EUDAMED
- Model / Reference
- 25T/kit EUDAMED52026117 EUDAMED50T/kit EUDAMED52027112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334813781 EUDAMEDD-FA0025Z8 EUDAMED
- Basic UDI-DI
- B-06950334813781 EUDAMEDB-FA0025Z8 EUDAMED
- EMDN Code
- W0102050215 ANTI-MULLERIAN HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 (AMH) Test Kit (Immunofluorescence) by Genrui Biotech 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-06950334813781 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 08ae441d-6a37-4bed-8db5-44be1a163455 61 fields · synced Jun 20, 2026
- EUDAMED 7b9edb06-d7e3-41c4-9bf9-b114ca06cfda 61 fields · synced May 19, 2026