Identity
- Trade Name
- SK300 EUDAMED
- Device Name
- BIOLIS 30i EUDAMED
- Model / Reference
- 60-01-9005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580262049840 EUDAMED
- Basic UDI-DI
- 458026201BIOLIS30i2W EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Sk300 by Biolis Medical Corp. — 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 | 458026201BIOLIS30i2W | Class A | Active |
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Manufacturer
- Manufacturer
- Biolis Medical Corp.
- EUDAMED SRN
- JP-MF-000025468
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 4aec41ba-5035-417b-9826-8f428408b2a4 61 fields · synced Jun 18, 2026