Identity
- Trade Name
- Electrosurgical pencils EUDAMED
- Device Name
- electrosurgical pencil EUDAMED
- Model / Reference
- ESRK4001Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971703290108 EUDAMED
- Basic UDI-DI
- B-16971703290108 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, 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 electrode, monopolar, single-use
Electrosurgical pencils by Dongguan QueenMed Equipment Mfg 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-16971703290108 | Class IIb | Active |
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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 2bed9269-c2ba-4918-b83b-34a3ae321ec8 61 fields · synced Jun 18, 2026