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TRAUS Series
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SAB-R15Ref SIP20510(k) K201292Ref SAB-S10Ref MBP10SXRef SAB-R30Ref SIP10
Identity
- Trade Name
- TRAUS Series EUDAMEDTRAUS SIP20 FDA UDI
- Generic Name
- Dental power tool system, line-powered FDA UDI
- Device Name
- TRAUS Series EUDAMEDBIP20+MBP10SL+FUS10+CRB46LN FDA UDI
- Model / Reference
- SAB-R15 EUDAMEDSIP20 EUDAMEDSAB-S10 EUDAMEDMBP10SX EUDAMEDSAB-R30 EUDAMEDSIP10 EUDAMEDTRAUS SIP20#1 FDA UDI
- Description
- BIP20+MBP10SL+FUS10+CRB46LN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809260471894 EUDAMED08809260471689 EUDAMEDFDA UDI08809260471863 EUDAMED08809260470187 EUDAMED08809260471870 EUDAMED08809260473133 EUDAMED08809260473744 EUDAMED
- Basic UDI-DI
- B-08809260471894 EUDAMEDB-08809260471689 EUDAMEDB-08809260471863 EUDAMEDB-08809260470187 EUDAMEDB-08809260471870 EUDAMEDB-08809260473133 EUDAMEDB-08809260473744 EUDAMED
- 510(k) Number
- K201292 FDA UDI
- FDA Product Code
- EBW FDA UDI
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental power tool system, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Belgium 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
TRAUS Series by Saeshin Precision Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201292 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809260471894 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Saeshin Precision Co., Ltd.
- EUDAMED SRN
- KR-MF-000016345
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (9)
- EUDAMED 46c7f6db-b5d9-45f1-9ee3-c0e153576ded 61 fields · synced Jul 27, 2026
- EUDAMED 26e9c0ad-6365-4155-87f0-fe4693cc8758 85 fields · synced May 17, 2026
- EUDAMED cd007212-9e56-4a1b-b9be-53fd8abf574f 61 fields · synced May 17, 2026
- EUDAMED 76113236-5374-4ebf-9624-85b38225c9ff 61 fields · synced May 18, 2026
- EUDAMED 5ed8586f-9c25-467a-8237-364f19216c0e 61 fields · synced May 19, 2026
- EUDAMED 0f4021c5-b050-43dc-a9de-060bd01d7f95 61 fields · synced May 19, 2026
- EUDAMED 7e189874-75fc-4190-b9db-17f2998cdae3 61 fields · synced May 19, 2026
- FDA UDI 1012ee42-e215-4b81-96ff-19e1feb25728 34 fields · synced May 30, 2026
- FDA 510(k) K201292 1 fields · synced May 18, 2026