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GE Blood Glucose Monitoring System GE200
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 280G01Model GM280Ref 750G01Model GM750
Identity
- Trade Name
- GE Blood Glucose Monitoring System GE200 EUDAMED
- Device Name
- Blood Glucose Monitoring System EUDAMED
- Model / Reference
- GM280 EUDAMED280G01 EUDAMEDGM750 EUDAMED750G01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GM280U6 EUDAMEDD-GM750UN EUDAMED
- Basic UDI-DI
- B-GM280U6 EUDAMEDB-GM750UN EUDAMED
- EMDN Code
- W0101060101,W01010699,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
GE Blood Glucose Monitoring System GE200 by Bionime Corporation — 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-GM280U6 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Bionime Corporation
- EUDAMED SRN
- TW-MF-000008450
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED ceeb5a0a-a847-4e13-8360-3132d5df0871 61 fields · synced Oct 6, 2026
- EUDAMED 7e410f18-9fc5-4571-a4fc-08e6140e0a00 61 fields · synced May 18, 2026