Identity
- Trade Name
- WHITEsmile fläsh After Whitening Mousse EUDAMED
- Device Name
- After Whitening Mousse EUDAMED
- Model / Reference
- 3485 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EWHI34851 EUDAMED
- Basic UDI-DI
- ++EWHITWAWM001CK EUDAMED
- EMDN Code
- Q019008 DENTINAL DESENSITISERS 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 After Whitening Mousse 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 | ++EWHITWAWM001CK | Class I | Active |
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Manufacturer
- Manufacturer
- WHITEsmile GmbH
- EUDAMED SRN
- DE-MF-000018734
Sources (1)
- EUDAMED d962adc4-efdd-4869-84a2-55f561079f4d 61 fields · synced Jul 15, 2026