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Ultrasonic Surgical Series
EUDAMEDClass IIa (EU MDR)
Ref SP-028iRef SP-020isRef SP-BT3Ref SP-ST1Ref SP-SAW RDRef SP-SAWLRef SP-SAWR
Identity
- Trade Name
- Ultrasonic Surgical Series EUDAMED
- Device Name
- Ultrasonic Surgical Series EUDAMED
- Model / Reference
- SP-028i EUDAMEDSP-020is EUDAMEDSP-BT3 EUDAMEDSP-ST1 EUDAMEDSP-SAW RD EUDAMEDSP-SAWL EUDAMEDSP-SAWR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260471924 EUDAMED08809260472020 EUDAMED08809260473058 EUDAMED08809260473089 EUDAMED08809260473096 EUDAMED08809260471962 EUDAMED08809260471979 EUDAMED
- Basic UDI-DI
- B-08809260471924 EUDAMEDB-08809260472020 EUDAMEDB-08809260473058 EUDAMEDB-08809260473089 EUDAMEDB-08809260473096 EUDAMEDB-08809260471962 EUDAMEDB-08809260471979 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
Ultrasonic Surgical Series by Saeshin Precision Co., Ltd. — Class IIa — 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-08809260471924 | 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 (7)
- EUDAMED e8074ec8-2cf4-46a0-9bbd-14c09ea98fe4 61 fields · synced Jul 28, 2026
- EUDAMED 1c75a40a-3972-481a-92c8-8fa93b1c0f5f 61 fields · synced May 18, 2026
- EUDAMED 6ff6eecb-023e-4530-af2c-77016c03ca66 61 fields · synced May 18, 2026
- EUDAMED 396ad460-f3d4-4966-925b-2237af46895f 61 fields · synced May 18, 2026
- EUDAMED 4e349fa7-0582-4230-a729-f8aecc146b6f 61 fields · synced May 18, 2026
- EUDAMED 63284564-2f7d-4856-860b-0178430e8326 61 fields · synced May 18, 2026
- EUDAMED ba939c25-0538-4fcf-a14f-d098e897f349 61 fields · synced May 19, 2026