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Electrosurgical pencil
EUDAMEDClass IIb (EU MDR)
Ref SY-IIIA(N)-1Model 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)-0Ref SY-IIIA(N)-0Ref SY-IIIB-1Ref SY-IIIA-0Ref SY-IIIA-1
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(N)-1 EUDAMEDSY-IIIA(N)-0 EUDAMEDSY-IIIB-1 EUDAMEDSY-IIIA-0 EUDAMEDSY-IIIA-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013965079 EUDAMED06972013965062 EUDAMED06972013965093 EUDAMED06972013965031 EUDAMED09327374039858 EUDAMED06972013966762 EUDAMED09327374039902 EUDAMED06972013966786 EUDAMED
- Basic UDI-DI
- 697201396MU2BSNYNSEP001V7 EUDAMED
- Direct Marketing DI
- 06972013965079 EUDAMED06972013965062 EUDAMED06972013965093 EUDAMED06972013965031 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 (11)
- EUDAMED e619bb03-cc79-47be-b4fa-d8ce5c5760f4 61 fields · synced Aug 1, 2026
- EUDAMED fcaa5d5c-ce3c-4294-b231-c8f41795f5b2 61 fields · synced May 17, 2026
- EUDAMED 29023e63-45c1-4a01-aefb-8e97a0cb1631 61 fields · synced May 18, 2026
- EUDAMED ff2d7034-4cfe-4cfc-a0c4-cb449b373724 61 fields · synced May 18, 2026
- EUDAMED a9043e17-0087-4932-b678-0cca0f8cbec4 61 fields · synced Jul 11, 2026
- EUDAMED eca3d710-83d6-408a-b0ac-306898a3827a 61 fields · synced Jul 14, 2026
- EUDAMED 8b35919b-8ed6-4515-8421-6b0d08d6c939 61 fields · synced Jul 16, 2026
- EUDAMED 05aa4236-4723-4182-b160-4ef4434cb665 61 fields · synced Jul 17, 2026
- EUDAMED b67fabda-ee74-4c3b-9c44-3bf9e5b21b6c 61 fields · synced Jul 18, 2026
- EUDAMED 37466475-cf4f-4eb3-88ab-78dfd5fce446 61 fields · synced Jul 25, 2026
- EUDAMED a3693602-6207-4af9-a9a5-1fb823539cae 61 fields · synced Aug 1, 2026