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Disposable Electrosurgical Pencil
EUDAMEDClass IIb (EU MDR)
Ref OBS-DiRef OBS-DaRef OBS-DfRef OBS-DtRef OBS-DlRef OBS-DcRef OBS-Ds
Identity
- Trade Name
- Disposable Electrosurgical Pencil EUDAMED
- Device Name
- Electrosurgical pencil EUDAMED
- Model / Reference
- OBS-Di EUDAMEDOBS-Da EUDAMEDOBS-Df EUDAMEDOBS-Dt EUDAMEDOBS-Dl EUDAMEDOBS-Dc EUDAMEDOBS-Ds EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939411510379 EUDAMED06939411510393 EUDAMED06939411510300 EUDAMED06939411510317 EUDAMED06939411510324 EUDAMED06939411510362 EUDAMED06939411510348 EUDAMED
- Basic UDI-DI
- B-06939411510379 EUDAMEDB-06939411510393 EUDAMEDB-06939411510300 EUDAMEDB-06939411510317 EUDAMEDB-06939411510324 EUDAMEDB-06939411510362 EUDAMEDB-06939411510348 EUDAMED
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Disposable Electrosurgical Pencil by Baisheng Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
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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-06939411510379 | 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 (7)
- EUDAMED ecdad0b5-b665-42e9-b9ec-f2875d47ee13 61 fields · synced Oct 6, 2026
- EUDAMED 581b1bcc-16b0-4279-81e9-31a3fb9f2a85 61 fields · synced May 16, 2026
- EUDAMED 33985f39-29c9-4044-8272-e5a9ebfb4750 61 fields · synced May 16, 2026
- EUDAMED 34439aec-685e-4163-93dc-b7957b1324c5 61 fields · synced May 17, 2026
- EUDAMED 0dfc6482-e2a7-4cbc-81ca-0df32b876dd8 61 fields · synced May 17, 2026
- EUDAMED 0c09ee5b-5c34-4617-b3f5-a59e3f940016 61 fields · synced May 18, 2026
- EUDAMED b88ea6bd-2741-40c2-9ac7-0059921e8884 61 fields · synced May 18, 2026