← Back to catalogue
Electrosurgical Generator
EUDAMEDClass IIb (EU MDR)
Ref OBS-350ARef OBS-350A OBS-350B OBS-300A OBS-100A OBS-100B OBS-100C OBS-50 Model OBS-350A OBS-350B OBS-300A OBS-100A OBS-100B OBS-100C OBS-50
Identity
- Trade Name
- Electrosurgical Generator EUDAMED
- Device Name
- Electrosurgical Generator EUDAMED
- Model / Reference
- OBS-350A EUDAMEDOBS-350A OBS-350B OBS-300A OBS-100A OBS-100B OBS-100C OBS-50 EUDAMEDOBS-350A OBS-350B OBS-300A OBS-100A OBS-100B OBS-100C OBS-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939411508277 EUDAMED
- Basic UDI-DI
- B-06939411508277 EUDAMED69394115OBSEGUV EUDAMED
- Direct Marketing DI
- 06939411508277 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Foot-switch, electrical
Electrosurgical Generator by Baisheng Medical Co., Ltd. — Class IIb — MDR, 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/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06939411508277 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06939411508277 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baisheng Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000024558
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED e93a0bf3-f22c-44a8-8be6-7277b9562824 61 fields · synced Jul 16, 2026
- EUDAMED f90aea07-10f3-41eb-9461-4ff971c722d5 61 fields · synced May 18, 2026