Identity
- Trade Name
- POLYESTER MATRIX BAND - C/ 25 UNITS. EUDAMED
- Device Name
- ORTHODONTIC BANDS EUDAMED
- Model / Reference
- 10.411.002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898229803761 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/ 25 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 |
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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 e335b093-1447-42e4-bf09-b1ac46a4708e 61 fields · synced Jun 18, 2026