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Blood Glucose Meter
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 06971969565678Model GLM-77Ref 06971969566699Model GLM-78Ref 06971969563681Model AC-307Ref 308-2402171Model AC-308Ref GLM-76 Ref 06971969564121Model GLM-73Ref GLM-79
Identity
- Trade Name
- Blood Glucose Meter EUDAMED
- Device Name
- Blood Glucose Meter EUDAMED
- Model / Reference
- GLM-77 EUDAMED06971969565678 EUDAMEDGLM-78 EUDAMED06971969566699 EUDAMEDAC-307 EUDAMED06971969563681 EUDAMEDAC-308 EUDAMED308-2402171 EUDAMEDGLM-76 EUDAMEDGLM-73 EUDAMED06971969564121 EUDAMEDGLM-79 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971969565678 EUDAMED06971969565111 EUDAMED06971969566699 EUDAMED06971969563681 EUDAMED06971969563506 EUDAMED06971969565364 EUDAMED06971969564121 EUDAMED06971969565241 EUDAMED06971969566101 EUDAMED
- Basic UDI-DI
- B-06971969565678 EUDAMEDB-06971969565111 EUDAMEDB-06971969566699 EUDAMEDB-06971969563681 EUDAMEDB-06971969563506 EUDAMEDB-06971969565364 EUDAMEDB-06971969564121 EUDAMEDB-06971969565241 EUDAMEDB-06971969566101 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass IVD devices for self-testing EUDAMED
- Market of Registration
- Spain EUDAMEDGermany EUDAMEDItaly EUDAMEDCzechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
Blood Glucose Meter 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-06971969565678 | 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 (9)
- EUDAMED fe9f06a5-75ad-442a-bf77-9d5f98eeef0d 61 fields · synced Jul 29, 2026
- EUDAMED c03dc88f-cebf-4df3-a4ab-27a5db0bf4f2 61 fields · synced May 17, 2026
- EUDAMED 70da98f9-2efd-43a6-b18c-129d724153c0 61 fields · synced May 17, 2026
- EUDAMED 06d96812-f56b-4a9a-9144-a6c53042e168 61 fields · synced May 17, 2026
- EUDAMED a0a7557d-371d-4e7e-b088-0e3e31c438c2 61 fields · synced May 17, 2026
- EUDAMED f6ccf129-7c06-4aa1-8a79-2aae83863ab8 61 fields · synced May 18, 2026
- EUDAMED 84baaa73-32ce-4f5a-b146-58d5e8d1886f 61 fields · synced May 18, 2026
- EUDAMED 6e157467-8f0b-4d94-8549-59ad1c64e7fb 61 fields · synced May 19, 2026
- EUDAMED d6a12ec0-0cf7-4261-83b7-cb57c82ab9c3 61 fields · synced May 19, 2026