← Back to catalogue
RIGHTEST ALPHA Blood Glucose Monitoring System
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 551G01Model GM551
Identity
- Trade Name
- RIGHTEST ALPHA Blood Glucose Monitoring System EUDAMED
- Device Name
- Blood Glucose Monitoring System EUDAMED
- Model / Reference
- GM551 EUDAMED551G01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GM551UE EUDAMED
- Basic UDI-DI
- B-GM551UE EUDAMED
- EMDN Code
- W0101060101,W01010699,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Croatia 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 ALPHA 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-GM551UE | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bionime Corporation
- EUDAMED SRN
- TW-MF-000008450
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED dbd14ee5-88c6-48c9-bba1-4bbf63d1eb02 61 fields · synced Jun 18, 2026