Identity
- Trade Name
- Electrosurgical pencils EUDAMED
- Device Name
- electrosurgical electrode EUDAMED
- Model / Reference
- SP200-C101Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SP200C101QMH EUDAMED
- Basic UDI-DI
- B-SP200C101QMH 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
No
EUDAMED
Electrosurgical pencils by Dongguan QueenMed Equipment Mfg Co Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-SP200C101QMH | 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 c138e045-4c9a-43d5-9346-50d2b1d5dca8 61 fields · synced Jun 18, 2026