Identity
- Trade Name
- DiaRapid CEA Rapid Test Cassette EUDAMED
- Device Name
- DiaRapid CEA Rapid Test Cassette EUDAMED
- Model / Reference
- SCE-402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942598212493 EUDAMED
- Basic UDI-DI
- B-06942598212493 EUDAMED
- EMDN Code
- W0102160299 TUMOUR MARKER RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
DiaRapid CEA Rapid Test Cassette by Hangzhou Alltest Biotech.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-06942598212493 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED ecb36af2-6b8e-4df3-8841-b41b3604b9d8 61 fields · synced Oct 6, 2026