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Biocard™ Celiac Home
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 3-028-200
Identity
- Trade Name
- Biocard™ Celiac Home EUDAMED
- Device Name
- Biocard™ Celiac Home EUDAMED
- Model / Reference
- 3-028-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06416842928015 EUDAMED
- Basic UDI-DI
- B-06416842928015 EUDAMED
- EMDN Code
- W0102100602 TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Biocard™ Celiac Home by Labsystems Diagnostics Oy — Class IVD devices for self-testing — 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-06416842928015 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Labsystems Diagnostics Oy
- EUDAMED SRN
- FI-MF-000018281
Sources (1)
- EUDAMED 6bdfab43-a6e1-4e15-9110-a584eeda1775 61 fields · synced Jul 14, 2026