Identity
- Device Name
- WHITEsmile fläsh Lip Retractor EUDAMED
- Model / Reference
- 3491 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EWHI34911 EUDAMED
- Basic UDI-DI
- ++EWHITWLIP001CV EUDAMED
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
WHITEsmile fläsh Lip Retractor by WHITEsmile GmbH — 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 | ++EWHITWLIP001CV | Class I | Active |
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Manufacturer
- Manufacturer
- WHITEsmile GmbH
- EUDAMED SRN
- DE-MF-000018734
Sources (1)
- EUDAMED 0600eb82-833c-4d8a-a864-689a56240a2e 61 fields · synced Jul 11, 2026