Toolkit For Orthodontic Miniscrew
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Toolkit For Orthodontic Miniscrew EUDAMEDMorelli FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Toolkit For Orthodontic Miniscrew FDA UDI
- Model / Reference
- KIT DE FERRAMENTAS EUDAMED37.20.001 EUDAMEDFDA UDIREUSABLE INSTRUMENTS EUDAMED
- Description
- Toolkit For Orthodontic Miniscrew FDA UDI
Identifiers
- Catalog Number
- 37.20.001 FDA UDI
- Primary DI / UDI-DI
- 07895742180140 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742180140 EUDAMED7895742133FZ 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
Toolkit For Orthodontic Miniscrew by Dental Morelli Ltda. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742180140 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742180140 | 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 2aab23ff-bac5-4d55-b9be-626d472fe41a 61 fields · synced Jul 23, 2026
- EUDAMED 1dc64377-64cd-42ac-81bf-cd5f81a56b5f 61 fields · synced May 19, 2026
- FDA UDI 613dcb8f-7caa-40a7-9b07-c4634bed905c 35 fields · synced May 30, 2026