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Elastics
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 60.05.7108
by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda
Identity
- Trade Name
- ORTHOMETRIC ELASTOMERICS - CHAIN FDA UDI
- Generic Name
- Orthodontic inter-arch elastic band FDA UDI
- Device Name
- Elastics EUDAMEDORTHOMETRIC ELASTOMERICS- ELASTIC CHAIN 4,5M- LONG- GREY FDA UDI
- Model / Reference
- 60.05.7108 EUDAMEDFDA UDI
- Description
- ORTHOMETRIC ELASTOMERICS- ELASTIC CHAIN 4,5M- LONG- GREY FDA UDI
Identifiers
- Catalog Number
- 60.05.7108 FDA UDI
- Primary DI / UDI-DI
- 07908470704196 EUDAMEDFDA UDI
- Basic UDI-DI
- 79084707ELASTICZ8 EUDAMED
- FDA Product Code
- ECI FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
- GMDN Term
- Orthodontic inter-arch elastic band FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Elastics by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 79084707ELASTICZ8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- BR-MF-000026426
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED a4d36b6e-3289-4eae-8793-d662f7b3e27b 61 fields · synced Oct 9, 2026
- FDA UDI 283c2c25-08a5-4486-b069-f15acd1235c0 34 fields · synced May 30, 2026