Identity
- Device Name
- WHITEsmile fläsh Just 38% HP (mixed 30%) EUDAMED
- Model / Reference
- 3500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EWHI35001 EUDAMED
- Basic UDI-DI
- B-+EWHI35001 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 fläsh Just 38% HP (mixed 30%) 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-+EWHI35001 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WHITEsmile GmbH
- EUDAMED SRN
- DE-MF-000018734
Sources (1)
- EUDAMED d5df7566-46e2-49b9-a18d-25b924026efe 61 fields · synced Jun 18, 2026