Identity
- Trade Name
- HP MANDRELS REINFORCED EUDAMED
- Device Name
- ODONTOLOGY DEVICES - OTHER EUDAMED
- Model / Reference
- 10.501.010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898229808971 EUDAMED
- Basic UDI-DI
- 79085168mandrelsE6 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Hp Mandrels Reinforced by 3R Indústria E Comércio LTDA — 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 | 79085168mandrelsE6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3R Indústria E Comércio LTDA
- EUDAMED SRN
- BR-MF-000034808
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (1)
- EUDAMED ed166c00-5821-4820-9794-97b13b3e93f7 61 fields · synced Jul 12, 2026