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BioCLIA Autoimmune Reagent Kit dsDNA
EUDAMEDClass B (EU MDR)
Ref MY00097Model BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control SetModel dsDNA, 50 Tests/Kit
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit dsDNA EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMEDBioCLIA Autoimmune Reagent Kit, dsDNA EUDAMED
- Model / Reference
- BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMEDMY00097 EUDAMEDdsDNA, 50 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030402129 EUDAMED
- Basic UDI-DI
- 6924030BioCLIAAI3N EUDAMEDB-06924030402129 EUDAMED
- Direct Marketing DI
- 06924030402129 EUDAMED
- EMDN Code
- W0102100105 DS DNA - ANTIBODIES EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass 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
New Device
No
EUDAMED
BioCLIA Autoimmune Reagent Kit dsDNA by HOB Biotech Group Corp., Ltd. — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6924030BioCLIAAI3N | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 6924030BioCLIAAI3N | Class B | 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 77e95555-d07d-43c0-a46b-4b7c164c8dfd 61 fields · synced Aug 1, 2026
- EUDAMED c02ec1dd-34a9-4b50-b926-7486ae011bf3 61 fields · synced May 19, 2026