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Hexagonal Digital Key
EUDAMEDFDA UDIClass I (EU MDR)
Ref 37.20.013Model REUSABLE INSTRUMENTSModel KIT DE FERRAMENTAS
Identity
- Trade Name
- Hexagonal Digital Key EUDAMEDMorelli FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Hexagonal Digital Key FDA UDI
- Model / Reference
- REUSABLE INSTRUMENTS EUDAMED37.20.013 EUDAMEDFDA UDIKIT DE FERRAMENTAS EUDAMED
- Description
- Hexagonal Digital Key FDA UDI
Identifiers
- Catalog Number
- 37.20.013 FDA UDI
- Primary DI / UDI-DI
- 07895742181512 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742133FZ EUDAMEDB-07895742181512 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L150799 ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Dry Heat Sterilization FDA UDI
Hexagonal Digital Key by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 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 330993e0-fe1f-404e-b730-6bcd24333dda 61 fields · synced Jul 26, 2026
- EUDAMED 61200908-c5f8-4c7d-be66-d225fd9ebd35 61 fields · synced May 16, 2026
- FDA UDI 345acd85-8fad-4686-951b-747484f73219 35 fields · synced May 30, 2026