Identity
- Trade Name
- TRAUS ENDO Series EUDAMED
- Device Name
- TRAUS ENDO Series EUDAMED
- Model / Reference
- BAE05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260473300 EUDAMED
- Basic UDI-DI
- B-08809260473300 EUDAMED
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Electrical-only medical device connection cable, reusable
TRAUS ENDO Series by Saeshin Precision Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K212043 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K143411 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809260473300 | 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 (2)
- EUDAMED a5ef5783-1cd3-4231-a1b4-f7e1660afd3f 85 fields · synced Jun 18, 2026
- FDA 510(k) K212043 1 fields · synced May 18, 2026