Identity
- Trade Name
- Ultrasonic Surgical Series EUDAMED
- Device Name
- Ultrasonic Surgical Series EUDAMED
- Model / Reference
- SUS10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260473447 EUDAMED
- Basic UDI-DI
- B-08809260473447 EUDAMED
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
Ultrasonic Surgical Series by Saeshin Precision Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809260473447 | Class IIb | 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 (1)
- EUDAMED 79e90245-b1c8-46b6-9d6b-880969600656 61 fields · synced Jun 19, 2026