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Electrosurgical pencils
EUDAMEDClass IIb (EU MDR)
Ref ESPB4000LQRef SP200-C100SRef ESFD3001QRef ESPB4000BQRef SP200-N100QRef ESPB4000BLQRef ESPB4001ERBQRef SP200-C101SRef SP200-P10S/92647Ref SP200-C200SRef SP200-L45S
Identity
- Trade Name
- Electrosurgical pencils EUDAMED
- Device Name
- Electrosurgical pencils EUDAMEDelectrosurgical electrode EUDAMEDelectrosurgical pencil EUDAMED
- Model / Reference
- ESPB4000LQ EUDAMEDSP200-C100S EUDAMEDESFD3001Q EUDAMEDESPB4000BQ EUDAMEDSP200-N100Q EUDAMEDESPB4000BLQ EUDAMEDESPB4001ERBQ EUDAMEDSP200-C101S EUDAMEDSP200-P10S/92647 EUDAMEDSP200-C200S EUDAMEDSP200-L45S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971703290078 EUDAMEDD-SP200-C100S97 EUDAMEDD-ESFD3001Q3H EUDAMEDD-ESPB4000BQ22 EUDAMEDD-SP200-N100QCU EUDAMEDD-ESPB4000BLQXA EUDAMED16971703290092 EUDAMED16971703290603 EUDAMED16971703290573 EUDAMED16971703290122 EUDAMED16971703290160 EUDAMED
- Basic UDI-DI
- B-16971703290078 EUDAMEDB-SP200-C100S97 EUDAMEDB-ESFD3001Q3H EUDAMEDB-ESPB4000BQ22 EUDAMEDB-SP200-N100QCU EUDAMEDB-ESPB4000BLQXA EUDAMEDB-16971703290092 EUDAMEDB-16971703290603 EUDAMEDB-16971703290573 EUDAMEDB-16971703290122 EUDAMEDB-16971703290160 EUDAMED
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMEDK0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMEDK0201010301,K0201010801 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
EUDAMEDEUDAMED
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
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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-16971703290078 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dongguan QueenMed Equipment Mfg Co Ltd
- EUDAMED SRN
- CN-MF-000006969
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (11)
- EUDAMED bc9cf6d3-b77f-4a55-8b71-11af4fd649e1 61 fields · synced Jul 30, 2026
- EUDAMED d5920cdd-db1a-4c77-94a9-887f8f192f21 61 fields · synced May 17, 2026
- EUDAMED 44081706-4053-4268-ab75-a4f920d40c33 61 fields · synced May 17, 2026
- EUDAMED 6f39032d-5be4-410b-94f4-3260e0070280 61 fields · synced May 17, 2026
- EUDAMED f311e749-2bec-4153-aa95-0365b360ccc6 61 fields · synced May 18, 2026
- EUDAMED 9ad8c55a-7574-42d1-826b-c5c2b4008b74 61 fields · synced May 18, 2026
- EUDAMED d7baa754-e536-4c25-a90e-24b30ee1bcd1 61 fields · synced May 18, 2026
- EUDAMED e46ee866-7330-4d3f-9a64-a5b67a6031fc 61 fields · synced May 18, 2026
- EUDAMED ec4d64ff-c5f8-4383-90d8-7e7000f2c50f 61 fields · synced May 18, 2026
- EUDAMED a2235308-b7ce-48cc-b398-45d8dde83516 61 fields · synced May 18, 2026
- EUDAMED a6f7c670-33a7-4cd9-9587-1604880da76b 61 fields · synced May 19, 2026