Identity
- Trade Name
- 060 Mouthguard 12 Ud Dentaflux EUDAMED
- Device Name
- PLACAS PLASTICAS TERMOFORMABLES BLANDAS MOUTHGUARD /THERMOFORMING SHEETS SOFT MOUTHGUARD EUDAMED
- Model / Reference
- 060M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436042240258 EUDAMED
- Basic UDI-DI
- 843604224PLASTMOQ6 EUDAMED
- Direct Marketing DI
- 08436042240258 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
060 Mouthguard 12 Ud Dentaflux by J Ripoll Sl — 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 | 843604224PLASTMOQ6 | Class I | Active |
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Manufacturer
- Manufacturer
- J Ripoll Sl
- EUDAMED SRN
- ES-MF-000001256
Sources (1)
- EUDAMED 4ca8718d-0047-45a0-8d88-a43ce27f0ce9 61 fields · synced Jun 19, 2026