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Intraoral Elastic - Latex - Light 3/8"
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60.01.304Model LATEX EXTRAORAL ELASTICSModel LATEX ELASTICS
Identity
- Trade Name
- Intraoral Elastic - Latex - Light 3/8" EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- Intraoral Elastic - Latex - Light 3/8" FDA UDI
- Model / Reference
- LATEX EXTRAORAL ELASTICS EUDAMED60.01.304 EUDAMEDFDA UDILATEX ELASTICS EUDAMED
- Description
- Intraoral Elastic - Latex - Light 3/8" FDA UDI
Identifiers
- Catalog Number
- 60.01.304 FDA UDI
- Primary DI / UDI-DI
- 07895742133450 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742133450 EUDAMED7895742178GP 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 - Light 3/8" by Dental Morelli Ltda. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742133450 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742133450 | 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 4d5ffebc-c576-4a3c-90cc-05205b851f90 61 fields · synced Jun 18, 2026
- EUDAMED 535d322e-ad2a-4798-8adc-65b2294a1953 61 fields · synced May 19, 2026
- FDA UDI b2ef58b5-80c1-418d-a6a9-d085c03796a2 35 fields · synced May 30, 2026