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On Call Sure Blood Glucose Monitoring System
EUDAMEDFDA 510(k)Class IVD Annex II List B (EU MDR)
Ref G115-10UModel OGM-211
Identity
- Trade Name
- On Call Sure Blood Glucose Monitoring System EUDAMED
- Device Name
- On Call Sure Blood Glucose Monitoring System EUDAMED
- Model / Reference
- OGM-211 EUDAMEDG115-10U EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G115-10UJV EUDAMED
- Basic UDI-DI
- B-G115-10UJV EUDAMED
- EMDN Code
- W0101060101,W010106010801,W0201060102 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
Yes
EUDAMED
On Call Sure Blood Glucose Monitoring System by Acon Biotech (Hangzhou) Co., Ltd. — Class IVD Annex II List B — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181527 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-G115-10UJV | 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 82ed400b-325c-4b11-b048-c9fea1603f0e 61 fields · synced Oct 6, 2026
- FDA 510(k) K181527 1 fields · synced May 18, 2026