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Tensiometer of 50 to 500gf (cN) - color Green
EUDAMEDFDA UDIClass I (EU MDR)
Ref 75.02.008Model ORTHODONTIC TENSIOMETER
Identity
- Trade Name
- Tensiometer of 50 to 500gf (cN) - color Green EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic appliance force gauge FDA UDI
- Device Name
- Tensiometer of 50 to 500gf (cN) - color Green FDA UDI
- Model / Reference
- ORTHODONTIC TENSIOMETER EUDAMED75.02.008 EUDAMEDFDA UDI
- Description
- Tensiometer of 50 to 500gf (cN) - color Green FDA UDI
Identifiers
- Catalog Number
- 75.02.008 FDA UDI
- Primary DI / UDI-DI
- 07895742009762 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742009762 EUDAMED7895742190GD EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L150705 ORTHODONTIC MEASUREMENT INSTRUMENTS, REUSABLE EUDAMED
- GMDN Term
- Orthodontic appliance force gauge 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
Tensiometer of 50 to 500gf (cN) - color Green by Dental Morelli Ltda. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-07895742009762 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742009762 | 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 8bfcb083-6c7b-43e7-a210-982694cea41c 61 fields · synced Oct 5, 2026
- EUDAMED af1bc284-f2fd-4208-a35d-578fc35188f7 61 fields · synced May 19, 2026
- FDA UDI cf9fc775-c6b6-41a2-81e2-0e3bf7dfc3e7 35 fields · synced May 30, 2026