Identity
- Trade Name
- RIGHTEST GD500 Lancing Device EUDAMED
- Device Name
- Lancing Device EUDAMED
- Model / Reference
- GD500 EUDAMEDR0B000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710949333157 EUDAMED
- Basic UDI-DI
- 471094933GD00001VG EUDAMED
- Direct Marketing DI
- 04710949333157 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
RIGHTEST GD500 Lancing Device by Bionime Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471094933GD00001VG | Class I | 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 6d35f3d1-c4bc-4a06-a7f1-e576a3900559 61 fields · synced Jul 13, 2026