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Soludiab
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref SCLMV-BTRef LGLMV‐BT‐01Model LGLMV-BT-01
Identity
- Trade Name
- Soludiab EUDAMED
- Device Name
- SCLMV-BT Control Solution EUDAMEDLGLMV-BT-01 Blood Glucose Monitoring System EUDAMED
- Model / Reference
- SCLMV-BT EUDAMEDLGLMV-BT-01 EUDAMEDLGLMV‐BT‐01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-T05G2J10012SNX6 EUDAMEDD-T05G2J10011KNW9 EUDAMED
- Basic UDI-DI
- B-T05G2J10012SNX6 EUDAMEDB-T05G2J10011KNW9 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMEDW0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
Soludiab by Tyson Bioresearch, Inc. — 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-T05G2J10012SNX6 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Tyson Bioresearch, Inc.
- EUDAMED SRN
- TW-MF-000027508
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 2ad24226-24d0-481f-9b31-103ba88703aa 61 fields · synced Aug 2, 2026
- EUDAMED 0120989a-8b97-495f-b915-73ab0c83423d 61 fields · synced May 18, 2026