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Carcinoembryonic Antigen Kit (CEA)(CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref FG1206YModel 100T
Identity
- Trade Name
- Carcinoembryonic Antigen Kit (CEA)(CLIA) EUDAMED
- Device Name
- Carcinoembryonic Antigen Kit (CEA)(CLIA) EUDAMED
- Model / Reference
- 100T EUDAMEDFG1206Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595751284 EUDAMED
- Basic UDI-DI
- B-06936595751284 EUDAMED
- EMDN Code
- W0102030112 CARCINOEMBRYONIC ANTIGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Carcinoembryonic Antigen Kit (CEA)(CLIA) by Medicalsystem Biotechnology 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-06936595751284 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b48139a6-7600-47ae-b18b-7215022b68ac 61 fields · synced Jun 18, 2026