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BioCLIA System Substrate
EUDAMEDClass A (EU MDR)
Ref MY01891Model Sample Diluent I, System Wash Buffer,System SubstrateRef MY00405
Identity
- Trade Name
- BioCLIA System Substrate EUDAMED
- Device Name
- BioCLIA Sample Diluent I,BioCLIA System Wash Buffer,BioCLIA System Substrate EUDAMED
- Model / Reference
- Sample Diluent I, System Wash Buffer,System Substrate EUDAMEDMY01891 EUDAMEDMY00405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030414849 EUDAMED06924030405205 EUDAMED
- Basic UDI-DI
- 6924030BioCLIACR4E EUDAMED
- Direct Marketing DI
- 06924030414849 EUDAMED06924030405205 EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 System Substrate by HOB Biotech Group Corp., Ltd. — Class A — 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 | 6924030BioCLIACR4E | Class A | 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 2eb5e30f-04f0-471d-ae11-2012f2a193c5 61 fields · synced Jul 22, 2026
- EUDAMED 3261c584-231e-4d19-824f-e00cb4c13aa0 61 fields · synced May 19, 2026