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060 Mouthguard 25 Sheets Dentaflux
EUDAMEDClass I (EU MDR)
Ref 060M25
by J Ripoll Sl
Identity
- Trade Name
- 060 Mouthguard 25 Sheets Dentaflux EUDAMED
- Device Name
- PLACAS PLASTICAS TERMOFORMABLES BLANDAS MOUTHGUARD /THERMOFORMING SHEETS SOFT MOUTHGUARD EUDAMED
- Model / Reference
- 060M25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436042241293 EUDAMED
- Basic UDI-DI
- 843604224PLASTMOQ6 EUDAMED
- Direct Marketing DI
- 08436042241293 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 25 Sheets 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 b89f5ed9-8684-487b-860b-2b697ae1d5b3 61 fields · synced Sep 18, 2026