Elastic Chain Short Baby Rose - 1, 5m
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Elastic Chain Short Baby Rose - 1,5m EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- Elastic Chain Short Baby Rose - 1,5m FDA UDI
- Model / Reference
- ELASTIC CHAIN EUDAMED60.05.119 EUDAMEDFDA UDI
- Description
- Elastic Chain Short Baby Rose - 1,5m FDA UDI
Identifiers
- Catalog Number
- 60.05.119 FDA UDI
- Primary DI / UDI-DI
- 07895742154141 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742154141 EUDAMED7895742177GM EUDAMED
- FDA Product Code
- ECI FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
- GMDN Term
- Orthodontic archwire/bracket ligature FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthodontic retainer
The Elastic Chain Short Baby Rose - 1, 5m is a medical device designed for the administration of basic medicinal products in pediatric patients. It features an implantable component and is subject to the relevant regulatory guidelines.
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Also classified as Orthodontic retainer.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742154141 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742154141 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (3)
- EUDAMED cc135add-2895-441f-94de-4f79c2629c2d 61 fields · synced Jul 11, 2026
- EUDAMED c9efdc34-e71d-4d0f-89d5-9a760b15ec22 61 fields · synced May 19, 2026
- FDA UDI e853fe02-2019-4c2e-8ba4-f4764fac497e 35 fields · synced May 30, 2026