Identity
- Trade Name
- Electrosurgical pencils EUDAMED
- Device Name
- electrosurgical pencil EUDAMED
- Model / Reference
- ESPB4001ERBLQ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ESPB4001ERBLQAB EUDAMED
- Basic UDI-DI
- B-ESPB4001ERBLQAB EUDAMED
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Electrosurgical pencils by Dongguan QueenMed Equipment Mfg Co Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
- PlasmaBlade™ — MEDTRONIC NAVIGATION, INC. · Class II
- Victan — Jiangsu Haize Medical Scientific Development Co., Ltd. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Bovie — SYMMETRY SURGICAL INC. · Class II
- Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr — KIRWAN SURGICAL PRODUCTS LLC · Class IIb
- Valleylab — Covidien LP · Class II
- A&E Medical / Disposable Suction Coagulator — A & E MEDICAL CORPORATION · Class II
- PlasmaBladeTM — MEDTRONIC NAVIGATION, 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-ESPB4001ERBLQAB | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dongguan QueenMed Equipment Mfg Co Ltd
- EUDAMED SRN
- CN-MF-000006969
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 2553d4ea-731c-4d4c-993e-4e98887c067a 61 fields · synced Jun 18, 2026