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BioCLIA Autoimmune Reagent Kit, dsDNA
EUDAMEDClass IVD General (EU MDR)
Ref MY00148Model dsDNA,100 Tests/KitRef MY00097CModel dsDNA, 50 Tests/Kit
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit, dsDNA EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit, dsDNA EUDAMED
- Model / Reference
- dsDNA,100 Tests/Kit EUDAMEDMY00148 EUDAMEDdsDNA, 50 Tests/Kit EUDAMEDMY00097C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030402631 EUDAMED06924030415464 EUDAMED
- Basic UDI-DI
- B-06924030402631 EUDAMEDB-06924030415464 EUDAMED
- EMDN Code
- W0102100105 DS DNA - ANTIBODIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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, dsDNA 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-06924030402631 | 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 (2)
- EUDAMED d4fa8561-67e4-4b8e-88a7-db5c9a138402 61 fields · synced Aug 1, 2026
- EUDAMED ab18ea23-2732-4fcb-b014-bd8b46c93716 61 fields · synced May 16, 2026