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Dura-Chain Wide Link (Red label)
EUDAMEDClass I (EU MDR)
Ref 3005-249Model Orthodontic Dura-Chain
Identity
- Trade Name
- Dura-Chain Wide Link (Red label) EUDAMED
- Device Name
- Orthodontic Dura-Chain EUDAMED
- Model / Reference
- Orthodontic Dura-Chain EUDAMED3005-249 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056334600367 EUDAMED
- Basic UDI-DI
- 50563346DURA-CHAINSUI2Z EUDAMED
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
Category: Orthodontic retainer
Dura-Chain Wide Link (Red label) by Ortho-Care (UK) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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- MASTER POUCH 15 2G 3/16 LT COUGAR — Ormco Corporation · Class IIa
- Pre-Finisher — TP ORTHODONTICS, INC. · Class I
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Stainless Steel Spring — American Orthodontics · Class IIa
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 | 50563346DURA-CHAINSUI2Z | Class I | Active |
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Manufacturer
- Manufacturer
- Ortho-Care (UK) Limited
- EUDAMED SRN
- GB-MF-000010884
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED d46621af-f9fc-454b-8359-97a54b568444 61 fields · synced Jul 20, 2026