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Blood Glucose Test Strips
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 697196956AH9Model AC-307Ref GLS-79Ref GLS-75Model GLS-79 Ref 06971969565203Ref AC-303Ref 06971969569577Model GLS-78Ref AC-309Model AC-308
Identity
- Trade Name
- Blood Glucose Test Strips EUDAMED
- Device Name
- Blood Glucose Test Strips EUDAMED
- Model / Reference
- AC-307 EUDAMED697196956AH9 EUDAMEDGLS-79 EUDAMEDGLS-75 EUDAMED06971969565203 EUDAMEDAC-303 EUDAMEDGLS-78 EUDAMED06971969569577 EUDAMEDAC-309 EUDAMEDAC-308 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971969563698 EUDAMED06971969565746 EUDAMED06971969565739 EUDAMED06971969565258 EUDAMED06971969565203 EUDAMED06971969563490 EUDAMED06971969569577 EUDAMED06971969566071 EUDAMED06971969563513 EUDAMED06971969560604 EUDAMED
- Basic UDI-DI
- B-06971969563698 EUDAMEDB-06971969565746 EUDAMEDB-06971969565739 EUDAMEDB-06971969565258 EUDAMEDB-06971969565203 EUDAMEDB-06971969563490 EUDAMEDB-06971969569577 EUDAMEDB-06971969566071 EUDAMEDB-06971969563513 EUDAMEDB-06971969560604 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMEDCzechia EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Blood Glucose Test Strips 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-06971969563698 | 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 (10)
- EUDAMED c49a1778-1b35-469a-8a60-f12206c81e5f 61 fields · synced Jul 26, 2026
- EUDAMED bd2e1c72-d0a8-41b9-b1e3-de0d52ffb530 61 fields · synced May 17, 2026
- EUDAMED c1d7abe2-c088-4b77-9f18-a923518dff12 61 fields · synced May 17, 2026
- EUDAMED 2ac5a468-3642-4547-aac9-ae858191086d 61 fields · synced May 17, 2026
- EUDAMED f26e3fda-678c-4b1e-ab7b-336a7b83ebe0 61 fields · synced May 18, 2026
- EUDAMED aff79790-6332-4c47-be55-b3df10096d45 61 fields · synced May 18, 2026
- EUDAMED 6ccd6ccc-c354-4bd7-9baa-21b6cd522fa6 61 fields · synced May 18, 2026
- EUDAMED 2cbee897-e4a2-4bf0-a388-a0329a3151dd 61 fields · synced May 18, 2026
- EUDAMED 80fd4a9b-c8f5-4753-8764-1549624eb42b 61 fields · synced May 18, 2026
- EUDAMED 81157271-ddb5-41b9-a8af-466e6629f4ca 61 fields · synced May 19, 2026