Pink Toolkit For Orthodontic Miniscrew
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Pink Toolkit For Orthodontic Miniscrew EUDAMEDMorelli FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Pink Toolkit For Orthodontic Miniscrew FDA UDI
- Model / Reference
- REUSABLE INSTRUMENTS EUDAMED37.20.003 EUDAMEDFDA UDIKIT DE FERRAMENTAS EUDAMED
- Description
- Pink Toolkit For Orthodontic Miniscrew FDA UDI
Identifiers
- Catalog Number
- 37.20.003 FDA UDI
- Primary DI / UDI-DI
- 07895742289348 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742133FZ EUDAMEDB-07895742289348 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Dental torque wrench FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Pink Toolkit For Orthodontic Miniscrew by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742133FZ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742133FZ | 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 e0864f6f-a03a-4708-b24c-3ef288f093a8 61 fields · synced Jul 11, 2026
- EUDAMED c42ae6ce-c5dc-455b-b783-5bdb44e3b4ca 61 fields · synced May 17, 2026
- FDA UDI cc5268ee-ed46-422e-860c-44f1eabb05c7 35 fields · synced May 29, 2026