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Solus V2 Glucose Control Solution
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref GCS
Identity
- Trade Name
- Solus V2 Glucose Control Solution EUDAMED
- Device Name
- Solus V2 Glucose Control Solution EUDAMED
- Model / Reference
- GCS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712803568330 EUDAMED
- Basic UDI-DI
- B-04712803568330 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Solus V2 Glucose Control Solution by Ok Biotech Co., Ltd. — Class IVD Annex II List B — 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-04712803568330 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- OK biotech co., Ltd
- EUDAMED SRN
- TW-MF-000028031
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 556ddc4a-09a7-4eab-93b1-2c34db74eeaf 61 fields · synced Jul 16, 2026