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Electrosurgical Generator
EUDAMEDClass IIb (EU MDR)
Ref OBS-350BRef OBS-100CRef OBS-100BRef OBS-300A
Identity
- Trade Name
- Electrosurgical Generator EUDAMED
- Device Name
- Electrosurgical Generator EUDAMED
- Model / Reference
- OBS-350B EUDAMEDOBS-100C EUDAMEDOBS-100B EUDAMEDOBS-300A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939411510959 EUDAMED06939411508314 EUDAMED06939411508307 EUDAMED06939411508284 EUDAMED
- Basic UDI-DI
- B-06939411510959 EUDAMEDB-06939411508314 EUDAMEDB-06939411508307 EUDAMEDB-06939411508284 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland 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: Foot-switch, electrical
Electrosurgical Generator by Baisheng Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06939411510959 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Baisheng Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000024558
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (4)
- EUDAMED c043b150-bb01-43d5-b9d0-0f19e2ebc3a5 61 fields · synced Jul 25, 2026
- EUDAMED 30d0e4b4-e3b8-403e-a6ff-31e22e8b0386 61 fields · synced May 16, 2026
- EUDAMED a74d7bba-be21-4606-82f5-56033f76df4b 61 fields · synced May 18, 2026
- EUDAMED 5f689cf3-1cfb-465d-89ac-ac5103f4a46a 61 fields · synced May 18, 2026