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Electrosurgical pencil
EUDAMEDClass IIb (EU MDR)
Ref SY-IIIA-2Model SY-IIIA-0、SY-IIIA-1、SY-IIIA-2、SY-IIIA(N)-0、SY-IIIA(N)-1； SY-IIIB-0、SY-IIIB-1、SY-IIIB-2、SY-IIIB(Q)-0
Identity
- Trade Name
- Electrosurgical pencil EUDAMED
- Device Name
- Electrosurgical pencil EUDAMED
- Model / Reference
- SY-IIIA-0、SY-IIIA-1、SY-IIIA-2、SY-IIIA(N)-0、SY-IIIA(N)-1； SY-IIIB-0、SY-IIIB-1、SY-IIIB-2、SY-IIIB(Q)-0 EUDAMEDSY-IIIA-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013965055 EUDAMED
- Basic UDI-DI
- 697201396MU2BSNYNSEP001V7 EUDAMED
- Direct Marketing DI
- 06972013965055 EUDAMED
- EMDN Code
- K0201010201 OPEN ELECTROSURGERY DISSECTORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Electrosurgical pencil by Multigate Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697201396MU2BSNYNSEP001V7 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (2)
- EUDAMED fab6b1a3-d875-4fd7-9e61-e34186326d29 61 fields · synced Jun 18, 2026
- EUDAMED 96bee2ba-47d8-4ec0-ada6-aece9456976d 61 fields · synced Jun 18, 2026