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saneo® SV-SC 01 Glucose Control Solution
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref SV-SC 01Model Glucose Control Solution
Identity
- Trade Name
- saneo® SV-SC 01 Glucose Control Solution EUDAMED
- Device Name
- saneo® SV-SC 01 Glucose Control Solution EUDAMED
- Model / Reference
- Glucose Control Solution EUDAMEDSV-SC 01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06424180100840 EUDAMED
- Basic UDI-DI
- B-06424180100840 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Romania 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
saneo® SV-SC 01 Glucose Control Solution by Eps Bio Technology Corp. — Class IVD devices for self-testing — IVDD — listed in EUDAMED
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-06424180100840 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- EPS Bio Technology Corp.
- EUDAMED SRN
- TW-MF-000028384
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 7cac1ed5-5ce6-418d-b832-bfd361736813 61 fields · synced Jun 19, 2026