Identity
- Device Name
- Extra-oral Headgear EUDAMED
- Model / Reference
- CPRB10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10195291009805 EUDAMED
- Basic UDI-DI
- 0195291Headgear79 EUDAMED
- Unit of Use DI
- 00195291009808 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Extra-oral Headgear by Flexmedics — 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 | 0195291Headgear79 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Flexmedics
- EUDAMED SRN
- US-MF-000013090
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED fb7d324d-b749-4338-97bb-7bdedf625f70 61 fields · synced Jul 24, 2026