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Universal Rotator Elastic - Gray
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60.07.201Model ROTATOR ELASTIC
Identity
- Trade Name
- Universal Rotator Elastic - Gray EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- Universal Rotator Elastic - Gray FDA UDI
- Model / Reference
- ROTATOR ELASTIC EUDAMED60.07.201 EUDAMEDFDA UDI
- Description
- Universal Rotator Elastic - Gray FDA UDI
Identifiers
- Catalog Number
- 60.07.201 FDA UDI
- Primary DI / UDI-DI
- 07895742286637 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742286637 EUDAMED7895742180GA 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
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
Category: Orthodontic retainer
Universal Rotator Elastic - Gray by Dental Morelli Ltda. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic retainer.
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- 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 (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-07895742286637 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742286637 | 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 a8f90fa8-8678-4f89-a025-ad9bec80264e 61 fields · synced Jul 24, 2026
- EUDAMED 627d08ae-ec6d-4700-aacc-5e20c9ce92cb 61 fields · synced May 19, 2026
- FDA UDI d301e0c8-7291-4f5b-98c4-c7094f21a20b 35 fields · synced May 30, 2026