Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Device Name

Bipolar Open -surgery Electrosurgical Handpiece (including electrode) for Single-use

Model / Reference

HN-230 W 0.4 ZXC Ⅱ, HN-210 S 0.7 ZZC Ⅱ, HN-200 S 0.7 XZC Ⅱ, HN-250 W 0.4 XZC Ⅱ, HN-200 S 2.0 ZZZ Ⅱ, HN-180 S 2.0 ZZZ Ⅱ, HN-270 S 0.4 ZZZ Ⅱ, HN-270 W 1.0 ZZZ Ⅱ, HN-155 W 0.4 ZZZ Ⅱ, HN-100 W 0.4 ZZZ Ⅱ, HN-230 W 0.4 XZC Ⅱ, HN-230 W 0.7 XZC Ⅱ, HN-270 W 0.4 ZZZ Ⅱ, HN-270 W 0.4 XZC Ⅱ, HN-240 W 0.4 ZZZ Ⅱ, HN-200 S 0.4 XZC Ⅱ, HN-300 W 2.0 XZC Ⅱ, HN-125 S 0.4 ZZZ Ⅱ, HN-210 S 0.7 XZC Ⅱ, HN-230 S 0.4 XZC Ⅱ, HN-210 W 0.4 XZC Ⅱ, HN-190 S 0.7 ZZC Ⅱ, HN-230 S 0.4 XSC Ⅱ, HN-230 S 0.4 ZZC Ⅱ, HN-270 S 0.7 ZZZ Ⅱ, HN-260 W 0.4 XZC Ⅱ, HN-210 S 0.7 SZC Ⅱ, HN-210 W 0.7 XZC Ⅱ, HN-230 S 0.7 SXC Ⅱ, HN-300 W 0.4 XZC Ⅱ, HN-160 S 0.4 XZC Ⅱ, HN-160 W 0.7 ZZZ Ⅱ, HN-150 S 0.4 ZZZ Ⅱ, HN-230 S 0.7 XZC Ⅱ, HN-240 S 0.7 ZZZ Ⅱ, HN-180 S 0.7 XZC Ⅱ, HN-280 W 0.4 XZC Ⅱ, HN-210 S 0.4 XZC Ⅱ, HN-210 S 1.0 XZC Ⅱ, HN-220 S 0.7 XZC Ⅱ, HN-270 S 1.0 ZZZ Ⅱ, HN-190 S 2.5 ZZZ Ⅱ, HN-300 W 2.5 XZC Ⅱ, HN-120 W 0.4 ZZZ Ⅱ, HN-125 W 0.4 ZZZ Ⅱ, HN-130 W 0.4 ZZZ Ⅱ

Primary DI / UDI-DI

06920907004175, 06920907004793, 06920907026641, 06920907026306, 06920907026658, 06920907026269, 06920907013658, 06920907013771, 06920907026252, 06920907026207, 06920907004861, 06920907004779, 06920907013566, 06920907013320, 06920907013542, 06920907004014, 06920907013092, 06920907004298, 06920907004045, 06920907004151, 06920907013559, 06920907004892, 06920907026467, 06920907004083, 06920907029703, 06920907026498, 06920907026665, 06920907004786, 06920907026474, 06920907013610, 06920907004854, 06920907026610, 06920907004915, 06920907004069, 06920907013177, 06920907004878, 06920907004748, 06920907004038, 06920907004427, 06920907026443, 06920907013788, 06920907026634, 06920907013443, 06920907026214, 06920907013573, 06920907026238, 06920907004021, 06920907029710

Basic UDI-DI

B-06920907004175, B-06920907004793, B-06920907026641, B-06920907026306, B-06920907026658, B-06920907026269, B-06920907013658, B-06920907013771, B-06920907026252, B-06920907026207, B-06920907004861, B-06920907004779, B-06920907013566, B-06920907013320, B-06920907013542, B-06920907004014, B-06920907013092, B-06920907004298, B-06920907004045, B-06920907004151, B-06920907013559, B-06920907004892, B-06920907026467, B-06920907004083, B-06920907029703, B-06920907026498, B-06920907026665, B-06920907004786, B-06920907026474, B-06920907013610, B-06920907004854, B-06920907026610, B-06920907004915, B-06920907004069, B-06920907013177, B-06920907004878, B-06920907004748, B-06920907004038, B-06920907004427, B-06920907026443, B-06920907013788, B-06920907026634, B-06920907013443, B-06920907026214, B-06920907013573, B-06920907026238, B-06920907004021, B-06920907029710

EMDN Code

K0201010601 Open electrosurgery forceps, single-use

Device Class

Class IIb

EU market of registration

Ireland

Iceland

EUDAMED SRN

CN-MF-000024518

Authorised representative

SUNGO Europe B.V. NL-AR-000000247

• Raney Clips Kit

  Class II

  FDA 510(k) K253814 Active Cleared 21 Jul 2026

• Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use

  Class IIb

  CE/MDD

• Sterile Raney Clips Kit

  Class IIa

  CE/MDR

• Multi-purpose Surgical Power Tool System

  Class IIa

  CE/MDD

• Operating Rack

  Class I

  CE/MDR

• Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use

  Class IIb

  CE/MDD

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