Identity
- Trade Name
- Dr.Oppel EUDAMED
- Device Name
- High Frequency Electrosurgical Device including electrode and associated accessories EUDAMED
- Model / Reference
- ST-501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800065701018 EUDAMED
- Basic UDI-DI
- B-08800065701018 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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: Foot-switch, electrical
Dr.Oppel by Sometech Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Foot-switch, electrical.
- ElectrodeCRF — Cambridge Interventional LLC · Class IIb
- ElectrodeCRF — Cambridge Interventional LLC · Class IIb
- Alligature-E — Alan Electronic Systems Private Limited · Class IIb
- Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · U
- Arthrex® — Arthrex, Inc. · Class I
- CableAME — Cambridge Interventional LLC · Class IIb
- CORE — Stryker Corp. · Class II
- PowerPack — MICROLINE SURGICAL, INC. · Class II
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-08800065701018 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sometech Inc.
- EUDAMED SRN
- KR-MF-000023076
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 9234e228-e411-4872-90cc-55e393b4ea3a 61 fields · synced Jun 18, 2026