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RIGHTEST GM100 Blood Glucose Monitoring System
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 100G01Model GM100
Identity
- Trade Name
- RIGHTEST GM100 Blood Glucose Monitoring System EUDAMED
- Device Name
- Blood Glucose Monitoring System EUDAMED
- Model / Reference
- GM100 EUDAMED100G01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GM100T9 EUDAMED
- Basic UDI-DI
- B-GM100T9 EUDAMED
- EMDN Code
- W0101060101,W01010699,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Italy 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
RIGHTEST GM100 Blood Glucose Monitoring System 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-GM100T9 | 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 (1)
- EUDAMED d09f293b-548c-41d4-b913-906ea76706f3 61 fields · synced Jul 9, 2026