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BioCLIA Autoimmune Reagent Kit, Cardiolipin IgM
EUDAMEDClass B (EU MDR)
Ref MY02199CModel BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control SetRef MY00173Model Cardiolipin IgM, 100 Tests/Kit
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit, Cardiolipin IgM EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMEDBioCLIA Autoimmune Reagent Kit, Cardiolipin IgM EUDAMED
- Model / Reference
- BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMEDMY02199C EUDAMEDCardiolipin IgM, 100 Tests/Kit EUDAMEDMY00173 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030416447 EUDAMED06924030402884 EUDAMED
- Basic UDI-DI
- 6924030BioCLIAAI3N EUDAMEDB-06924030402884 EUDAMED
- Direct Marketing DI
- 06924030416447 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMEDW0102100501 ANTI-CARDIOLIPIN ANTIBODIES EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Croatia EUDAMEDGermany 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, Cardiolipin IgM 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 99fcea9d-ef9a-40fe-afae-a90bc1c829e1 61 fields · synced Jul 20, 2026
- EUDAMED 9b83ae89-f14f-44bf-b5c5-19e5365a548c 61 fields · synced May 17, 2026