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On Call GU Dual Blood Glucose and Uric Acid Meter
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref GU114-11DModel OGM-201
Identity
- Trade Name
- On Call GU Dual Blood Glucose and Uric Acid Meter EUDAMED
- Device Name
- On Call GU Dual Blood Glucose and Uric Acid Meter EUDAMED
- Model / Reference
- OGM-201 EUDAMEDGU114-11D EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GU114-11DK5 EUDAMED
- Basic UDI-DI
- B-GU114-11DK5 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing 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 GU Dual Blood Glucose and Uric Acid Meter by Acon Biotech (Hangzhou) Co., Ltd. — Class IVD devices for self-testing — 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-GU114-11DK5 | Class IVD devices for self-testing | 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 94eb9f3b-e13f-42e0-975b-a5405acd16df 61 fields · synced Oct 6, 2026