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AMH Gen II ELISA KIT
EUDAMEDClass B (EU MDR)
Ref D00324Model Immunoassay, D00324Ref A79765Model Immunoassay A79765
Identity
- Trade Name
- AMH Gen II ELISA KIT EUDAMEDAMH Gen II ELISA EUDAMED
- Device Name
- AMH Gen II ELISA KIT EUDAMEDAMH Gen II ELISA EUDAMED
- Model / Reference
- Immunoassay, D00324 EUDAMEDD00324 EUDAMEDImmunoassay A79765 EUDAMEDA79765 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590787486 EUDAMED15099590206703 EUDAMED
- Basic UDI-DI
- 150995905D00324RC EUDAMED150995905A79765VK EUDAMED
- EMDN Code
- W0102050215 ANTI-MULLERIAN HORMONE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Czechia 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
New Device
Yes
EUDAMEDEUDAMED
AMH Gen II ELISA KIT by IMMUNOTECH s.r.o. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995905D00324RC | Class B | Active |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (2)
- EUDAMED 93ff232c-2f14-4ea1-9024-8101b61abff5 61 fields · synced Jul 10, 2026
- EUDAMED 9327c538-6ea5-4a66-8dd4-59094df53330 61 fields · synced May 18, 2026