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On Call Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref GN112-111-201Model OGM-361
Identity
- Trade Name
- On Call Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer EUDAMED
- Device Name
- Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer EUDAMED
- Model / Reference
- OGM-361 EUDAMEDGN112-111-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921756497736 EUDAMED
- Basic UDI-DI
- B-06921756497736 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
On Call Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer by Acon Biotech (Hangzhou) Co., Ltd. — Class IVD General — 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-06921756497736 | Class IVD General | 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 194fc1b7-4473-4d1e-93da-b991b5d3e584 61 fields · synced Jul 9, 2026