← Back to catalogue
Protector bucal antibruxismo noche(export) 2
EUDAMEDClass I (EU MDR)
Ref BXCNIGE2Model BCXDAY
by Prim, S.a.
Identity
- Trade Name
- Protector bucal antibruxismo noche(export) 2 EUDAMED
- Device Name
- BRUXICALM EUDAMED
- Model / Reference
- BCXDAY EUDAMEDBXCNIGE2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048514496 EUDAMED
- Basic UDI-DI
- 843404825FERULADENTAL2U EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Protector bucal antibruxismo noche(export) 2 by Prim S.a. — 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 | 843404825FERULADENTAL2U | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (1)
- EUDAMED 9614fa70-6877-41d2-8ef2-63ac2bd4ef76 61 fields · synced Jul 30, 2026