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WHITEsmile Power Whitening YF 40% HP (mixed 32%)
EUDAMEDClass IIa (EU MDR)
Ref 5381
Identity
- Device Name
- WHITEsmile Power Whitening YF 40% HP (mixed 32%) EUDAMED
- Model / Reference
- 5381 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EWHI53811 EUDAMED
- Basic UDI-DI
- B-+EWHI53811 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
WHITEsmile Power Whitening YF 40% HP (mixed 32%) by WHITEsmile GmbH — Class IIa — 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-+EWHI53811 | Class IIa | Active |
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Manufacturer
- Manufacturer
- WHITEsmile GmbH
- EUDAMED SRN
- DE-MF-000018734
Sources (1)
- EUDAMED 293c826b-44f1-4d4d-adcf-998d8c170fb3 61 fields · synced Jul 26, 2026