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BioLISA FIgG Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref MB00289Model FIgG-90, 3×96 Tests/KitRef MB00288Model FIgG-80, 3×96 Tests/Kit
Identity
- Trade Name
- BioLISA FIgG Reagent Kit EUDAMED
- Device Name
- BioLISA FIgG Reagent Kit EUDAMED
- Model / Reference
- FIgG-90, 3×96 Tests/Kit EUDAMEDMB00289 EUDAMEDFIgG-80, 3×96 Tests/Kit EUDAMEDMB00288 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030412500 EUDAMED06924030412494 EUDAMED
- Basic UDI-DI
- B-06924030412500 EUDAMEDB-06924030412494 EUDAMED
- EMDN Code
- W01020208 ALLERGENE SPECIFIC IGG EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
BioLISA FIgG Reagent Kit 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-06924030412500 | 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 4abecd6d-8669-4024-87f3-87a1e6d501f6 61 fields · synced Jul 26, 2026
- EUDAMED a1649c0d-2f09-42b1-99ea-16e571cfcc21 61 fields · synced May 19, 2026