Identity
- Trade Name
- Torque Wrench EUDAMEDFDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- TW400B EUDAMEDFDA UDIHTW400B EUDAMEDFDA UDIHTW30 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000956459 EUDAMEDFDA UDI08800209374030 EUDAMEDFDA UDI08800209374023 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental torque wrench FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Torque Wrench by Osstem Implant Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 88000406CLASSIBS25V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000020006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (6)
- EUDAMED 395d369c-d400-4c80-84fc-9e31e44de0dc 61 fields · synced Jul 9, 2026
- FDA UDI bec9be30-97b6-41d2-8304-f7f607ae6cc2 32 fields · synced May 30, 2026
- FDA UDI 61e89e9d-2579-47ba-b92b-09dd9e94e150 32 fields · synced May 30, 2026
- FDA UDI 4d73be8f-3aa2-48f7-adde-a501d4546bd3 32 fields · synced May 30, 2026
- EUDAMED dab7496c-f53d-4751-938d-8c881559b060 61 fields · synced Jun 20, 2026
- EUDAMED 3d0c0158-49a9-469b-b7c9-4c4d78084ec7 61 fields · synced Jul 9, 2026