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On Call Sure Blood Glucose Meter
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref G115-11UModel OGM-211Ref G115-12U
Identity
- Trade Name
- On Call Sure Blood Glucose Meter EUDAMED
- Device Name
- On Call Sure Blood Glucose Meter EUDAMED
- Model / Reference
- OGM-211 EUDAMEDG115-11U EUDAMEDG115-12U EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G115-11UJY EUDAMEDD-G115-12UK3 EUDAMED
- Basic UDI-DI
- B-G115-11UJY EUDAMEDB-G115-12UK3 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS 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
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
On Call Sure Blood Glucose Meter by Acon Biotech (Hangzhou) Co., Ltd. — 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-G115-11UJY | 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 (2)
- EUDAMED 7a496e15-d2e0-4da6-bd47-f9297d79729d 61 fields · synced Oct 6, 2026
- EUDAMED 3896b59e-34d8-480c-a97f-22055b56636f 61 fields · synced May 17, 2026