Identity
- Trade Name
- BestShape EUDAMED
- Device Name
- BestShape Go EUDAMED
- Model / Reference
- BestShape Go EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892330015 EUDAMED
- Basic UDI-DI
- 471989233Go2X EUDAMED
- Direct Marketing DI
- 04719892330015 EUDAMED
- EMDN Code
- Y120606,Y122124,Y122127 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
BestShape by Wistron Medical Technology 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 | 471989233Go2X | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wistron Medical Technology Corporation
- EUDAMED SRN
- TW-MF-000028594
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED e7654b9f-ae20-40a2-bb32-d0406d63e592 61 fields · synced Jul 23, 2026