Identity
- Device Name
- Femlab Test EUDAMED
- Model / Reference
- V02-512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571802508 EUDAMED
- Basic UDI-DI
- B-06941571802508 EUDAMED
- EMDN Code
- W01010699 CLIN. CHEM. RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Femlab Test by Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. — 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-06941571802508 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020607
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 2411b55c-480f-4991-bc6b-7f6c26b59eb6 61 fields · synced Jun 20, 2026