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Hexagonal Key Short Stem
EUDAMEDFDA UDIClass I (EU MDR)
Ref 37.20.012Model KIT DE FERRAMENTASModel REUSABLE INSTRUMENTS
Identity
- Trade Name
- Hexagonal Key Short Stem EUDAMEDMorelli FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Hexagonal Key Short Stem FDA UDI
- Model / Reference
- KIT DE FERRAMENTAS EUDAMED37.20.012 EUDAMEDFDA UDIREUSABLE INSTRUMENTS EUDAMED
- Description
- Hexagonal Key Short Stem FDA UDI
Identifiers
- Catalog Number
- 37.20.012 FDA UDI
- Primary DI / UDI-DI
- 07895742181505 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742181505 EUDAMED7895742133FZ 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 Key Short Stem by Dental Morelli Ltda. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742181505 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742181505 | 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 c7c867c1-ca8d-4d9f-ba64-f952a3f83efb 61 fields · synced Aug 2, 2026
- EUDAMED 517f4068-4749-40a0-826c-dfbf6e9ebd13 61 fields · synced May 19, 2026
- FDA UDI 7b278b66-aeb3-4388-90af-98a3428862d0 35 fields · synced May 30, 2026