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BioCLIA Autoimmune Reagent Kit, ENA Screen I
EUDAMEDClass IVD General (EU MDR)
Ref MY00198Model ENA Screen I, 100 Tests/Kit
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit, ENA Screen I EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit, ENA Screen I EUDAMED
- Model / Reference
- ENA Screen I, 100 Tests/Kit EUDAMEDMY00198 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030403133 EUDAMED
- Basic UDI-DI
- B-06924030403133 EUDAMED
- EMDN Code
- W0102100102 ENA SCREENING EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
BioCLIA Autoimmune Reagent Kit, ENA Screen I by HOB Biotech Group Corp., 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-06924030403133 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- HOB Biotech Group Corp., Ltd.
- EUDAMED SRN
- CN-MF-000023974
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED f81d74d0-d245-45e1-bdbc-dbf8872e30d3 61 fields · synced Jun 18, 2026