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Tube Prescription Roth - Single .018" - Bonding - 26, 27 - Hook
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 20.11.112Model BRACKETS AND TUBES
Identity
- Trade Name
- Tube Prescription Roth - Single .018" - Bonding - 26,27 - Hook EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- Tube Prescription Roth - Single .018" - Bonding - 26,27 - Hook FDA UDI
- Model / Reference
- BRACKETS AND TUBES EUDAMED20.11.112 EUDAMEDFDA UDI
- Description
- Tube Prescription Roth - Single .018" - Bonding - 26,27 - Hook FDA UDI
Identifiers
- Catalog Number
- 20.11.112 FDA UDI
- Primary DI / UDI-DI
- 07895742009915 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742122FU EUDAMEDB-07895742009915 EUDAMED
- FDA Product Code
- DZD FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
MR Conditional FDA UDI
Tube Prescription Roth - Single .018" - Bonding - 26, 27 - Hook by Dental Morelli Ltda. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 7895742122FU | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7895742122FU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 3da74a27-ec0e-4551-9df0-047561683876 61 fields · synced Jul 12, 2026
- EUDAMED 55b7683b-6fea-48cc-80ec-a9d26af93294 61 fields · synced May 19, 2026
- FDA UDI 71b8cd2a-e06e-4040-be08-d7834433fd5d 35 fields · synced May 30, 2026