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BioCLIA Autoimmune Reagent Kit, PCA
EUDAMEDClass IVD General (EU MDR)
Ref MY00196Model PCA, 100 Tests/KitRef MY00145CModel PCA, 50 Tests/Kit
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit, PCA EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit, PCA EUDAMED
- Model / Reference
- PCA, 100 Tests/Kit EUDAMEDMY00196 EUDAMEDPCA, 50 Tests/Kit EUDAMEDMY00145C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030403119 EUDAMED06924030415921 EUDAMED
- Basic UDI-DI
- B-06924030403119 EUDAMEDB-06924030415921 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER 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, PCA 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-06924030403119 | 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 f2d246e0-6470-4777-9cad-dcab64e32d4f 61 fields · synced Jul 10, 2026
- EUDAMED 97a18651-7ff1-4f96-844c-cc5ab023e6e6 61 fields · synced May 17, 2026