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On Call Sure Blood Glucose Test Strips
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref G135-11UModel OGS-211
Identity
- Trade Name
- On Call Sure Blood Glucose Test Strips EUDAMED
- Device Name
- On Call Sure Blood Glucose Test Strips EUDAMED
- Model / Reference
- OGS-211 EUDAMEDG135-11U EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G135-11UKS EUDAMED
- Basic UDI-DI
- B-G135-11UKS EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS 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
Yes
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
On Call Sure Blood Glucose Test Strips by Acon Biotech (Hangzhou) Co., Ltd. — Class IVD Annex II List B — 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-G135-11UKS | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000006977
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 1a9ddb99-6fd1-49fd-9200-01811b911e5e 61 fields · synced Jun 18, 2026