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Intraoral Elastic - Latex Medium - 3/16"
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60.01.311Model LATEX ELASTICSModel LATEX EXTRAORAL ELASTICS
Identity
- Trade Name
- Intraoral Elastic - Latex Medium - 3/16" EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- Intraoral Elastic - Latex Medium - 3/16" FDA UDI
- Model / Reference
- LATEX ELASTICS EUDAMED60.01.311 EUDAMEDFDA UDILATEX EXTRAORAL ELASTICS EUDAMED
- Description
- Intraoral Elastic - Latex Medium - 3/16" FDA UDI
Identifiers
- Catalog Number
- 60.01.311 FDA UDI
- Primary DI / UDI-DI
- 07895742133474 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742178GP EUDAMEDB-07895742133474 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
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
Category: Orthodontic retainer
Intraoral Elastic - Latex Medium - 3/16" by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
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- Stainless Steel Spring — American Orthodontics · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742178GP | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742178GP | 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 83eafabf-b4ef-4039-8c8c-01b85c393fe9 61 fields · synced Jul 14, 2026
- EUDAMED 4042fe37-a9f5-401a-9f53-f4a4a8e312f9 61 fields · synced May 19, 2026
- FDA UDI ef1257e1-cef2-4039-ac80-e70959c97c6c 35 fields · synced May 30, 2026