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Hand Key
EUDAMEDFDA UDIClass I (EU MDR)
Ref 37.20.014Model KIT DE FERRAMENTASModel REUSABLE INSTRUMENTS
Identity
- Trade Name
- Hand Key EUDAMEDMorelli FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Hand Key FDA UDI
- Model / Reference
- KIT DE FERRAMENTAS EUDAMED37.20.014 EUDAMEDFDA UDIREUSABLE INSTRUMENTS EUDAMED
- Description
- Hand Key FDA UDI
Identifiers
- Catalog Number
- 37.20.014 FDA UDI
- Primary DI / UDI-DI
- 07895742190095 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742190095 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
Hand Key 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-07895742190095 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742190095 | 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 395afda6-1770-4f96-b89c-0217239de750 61 fields · synced Sep 18, 2026
- EUDAMED 2170709d-c45c-4600-81a1-fbc553b5e568 61 fields · synced May 19, 2026
- FDA UDI 867d59ea-fadf-4301-90c8-98161728a76c 35 fields · synced May 30, 2026