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BioCLIA Autoimmune Reagent Kit, Cardiolipin IgA
EUDAMEDClass B (EU MDR)
Ref MY02197CModel BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit, Cardiolipin IgA EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMED
- Model / Reference
- BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EUDAMEDMY02197C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030416409 EUDAMED
- Basic UDI-DI
- 6924030BioCLIAAI3N EUDAMED
- Direct Marketing DI
- 06924030416409 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Croatia 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 IgA by HOB Biotech Group Corp., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED ca4bbb0b-eaba-4d51-8996-9df68a8ed6f9 61 fields · synced Jun 18, 2026