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Blood Glucose Control Solutions
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref GCS-L2Ref GCS-L1
Identity
- Trade Name
- Blood Glucose Control Solutions EUDAMED
- Device Name
- Blood Glucose Control Solutions EUDAMED
- Model / Reference
- GCS-L2 EUDAMEDGCS-L1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971969566125 EUDAMED06971969566118 EUDAMED
- Basic UDI-DI
- B-06971969566125 EUDAMEDB-06971969566118 EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Blood Glucose Control Solutions by YASEE BioMedical 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-06971969566125 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- YASEE BioMedical Inc.
- EUDAMED SRN
- CN-MF-000037011
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 98a8cc71-a019-4edc-8c5b-c7565d8e36e6 61 fields · synced Aug 2, 2026
- EUDAMED e3b784ef-2f6f-4996-b5bd-367d33269f81 61 fields · synced May 19, 2026