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Intraoral Rhodium Plated Superelastic Archwire Large - NiTi - Round Ø0, 30mm (.…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50.60.135Model THREADS AND BOWS - Class I
Identity
- Trade Name
- Intraoral Rhodium Plated Superelastic Archwire Large - NiTi - Round Ø0,30mm (.012") EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Intraoral Rhodium Plated Superelastic Archwire Large - NiTi - Round Ø0,30mm (.012") FDA UDI
- Model / Reference
- THREADS AND BOWS - Class I EUDAMED50.60.135 EUDAMEDFDA UDI
- Description
- Intraoral Rhodium Plated Superelastic Archwire Large - NiTi - Round Ø0,30mm (.012") FDA UDI
Identifiers
- Catalog Number
- 50.60.135 FDA UDI
- Primary DI / UDI-DI
- 07895742252403 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742130FT EUDAMEDB-07895742252403 EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic archwire 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
Intraoral Rhodium Plated Superelastic Archwire Large - NiTi - Round Ø0, 30mm (.… by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED…
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 | 7895742130FT | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742130FT | 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 9434f5d9-aefc-462f-92db-a0d6d983cd20 61 fields · synced Oct 5, 2026
- EUDAMED 8890089c-2a21-41d6-933f-d71b6fb73c9d 61 fields · synced May 17, 2026
- FDA UDI f447ef29-eaf5-4504-b3eb-32c0af0ec105 35 fields · synced May 30, 2026