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On Call Plus Blood Glucose Meter
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref G113-211Model OGM-541Ref G113-214
Identity
- Trade Name
- On Call Plus Blood Glucose Meter EUDAMED
- Device Name
- On Call Plus Blood Glucose Meter EUDAMED
- Model / Reference
- OGM-541 EUDAMEDG113-211 EUDAMEDG113-214 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G113-211G9 EUDAMEDD-G113-214GF EUDAMED
- Basic UDI-DI
- B-G113-211G9 EUDAMEDB-G113-214GF 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 Plus 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-G113-211G9 | 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 f945010f-5d94-440e-be34-1cb417460596 61 fields · synced Jul 18, 2026
- EUDAMED 3b6e7fd1-2972-4f63-b5ae-f4dbe400cc98 61 fields · synced May 17, 2026