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Ratchet Handle
EUDAMEDFDA UDIClass I (EU MDR)
Ref T067228Model Reusable Surgical Instruments
by Teknimed Sas
Identity
- Trade Name
- Ratchet Handle EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Model / Reference
- Reusable Surgical Instruments EUDAMEDT067228 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- T067228 FDA UDI
- Primary DI / UDI-DI
- 03701505800139 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017704B27DC EUDAMED
- Direct Marketing DI
- 03701505800139 EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant template, reusable
Ratchet Handle by Teknimed Sas — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376017704B27DC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-MF-000001224
Sources (2)
- EUDAMED 676622cf-b3a9-43bd-87aa-1e5ca4132ec3 61 fields · synced Jul 27, 2026
- FDA UDI 115a9006-d24d-4253-b11f-4ca249227a0e 33 fields · synced May 30, 2026