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Lancing Device
EUDAMEDClass I (EU MDR)
Ref 500D01Model GD500Ref 720D01Model GD720
Identity
- Device Name
- Lancing Device EUDAMED
- Model / Reference
- GD500 EUDAMED500D01 EUDAMEDGD720 EUDAMED720D01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GD500RW EUDAMEDD-GD720SE EUDAMED
- Basic UDI-DI
- B-GD500RW EUDAMEDB-GD720SE EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDCzechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lancing Device by Bionime Corporation — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-GD500RW | Class I | 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 e88439ea-04d4-4f2d-b9b4-9bc08b70e3e7 61 fields · synced Jul 15, 2026
- EUDAMED f4f55993-0693-45a9-9e8f-ff75091bff4f 61 fields · synced May 18, 2026