Identity
- Trade Name
- POLYESTER MATRIX BAND - C/ 100 UNITS. EUDAMED
- Device Name
- ORTHODONTIC BANDS EUDAMED
- Model / Reference
- 10.411.001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898229803754 EUDAMED
- Basic UDI-DI
- 79085168bandmatrixLP EUDAMED
- EMDN Code
- Q010402 ORTHODONTIC BANDS 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
Polyester Matrix Band - C/ 100 Units. 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 | 79085168bandmatrixLP | 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 353bba41-314f-48d7-b771-8445a2e87b1f 61 fields · synced Jul 16, 2026