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BioCLIA Autoimmune Reagent Kit, PCNA
EUDAMEDClass IVD General (EU MDR)
Ref MY00106CModel PCNA, 50 Tests/KitRef MY00157Model PCNA, 100 Tests/Kit
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit, PCNA EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit, PCNA EUDAMED
- Model / Reference
- PCNA, 50 Tests/Kit EUDAMEDMY00106C EUDAMEDPCNA, 100 Tests/Kit EUDAMEDMY00157 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030415556 EUDAMED06924030402723 EUDAMED
- Basic UDI-DI
- B-06924030415556 EUDAMEDB-06924030402723 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMEDW0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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, PCNA 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-06924030415556 | 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 a6acb6e3-d610-4694-9484-8eb4a1c0700d 61 fields · synced Oct 6, 2026
- EUDAMED d21545ad-cfca-4cbd-a228-6bc9bf74720f 61 fields · synced May 18, 2026