Manufacturer

Mizuho

JapanLegal entities : MIZUHO Corporation

Markets : Austria · Bulgaria · Czechia · Denmark · Estonia · Finland · Germany · Greece · Hungary · Ireland · Italy · Netherlands · Norway · Poland · Portugal · Romania · Spain · United States

Approvals : EU – class I, III · United States (FDA) – 510(k) : 12 · class I, II · latest in 2022 · see on the FDA website

EU representative : Emergo Europe B.V. (Netherlands)

regulatory@mizuho.co.jp

5 categories, 197 models including 196 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Various neurology and neurosurgery instruments - other	Z12109099	Sugita Titanium Aneurysm Clip II Long Type No.19B4 refs Sugita Titanium Aneurysm Clip II Long Type No.19C93/42 Sugita Titanium Aneurysm Clip II Long Type No.9093/42 Sugita Titanium Aneurysm Clip II Long Type No.9193/42 Sugita Titanium Aneurysm Clip II Long Type No.9293/42 120 others Sugita Titanium Aneurysm Clip II Mini Type No.10093/42 Sugita Titanium Aneurysm Clip II Mini Type No.10193/42 Sugita Titanium Aneurysm Clip II Mini Type No.10293/42 Sugita Titanium Aneurysm Clip II Mini Type No.10393/42 Sugita Titanium Aneurysm Clip II Mini Type No.10493/42 Sugita Titanium Aneurysm Clip II Mini Type No.10593/42 Sugita Titanium Aneurysm Clip II Mini Type No.10693/42 Sugita Titanium Aneurysm Clip II Mini Type No.8093/42 Sugita Titanium Aneurysm Clip II Mini Type No.8193/42 Sugita Titanium Aneurysm Clip II Mini Type No.8393/42 Sugita Titanium Aneurysm Clip II Mini Type No.8493/42 Sugita Titanium Aneurysm Clip II Mini Type No.8593/42 Sugita Titanium Aneurysm Clip II Mini Type No.8693/42 Sugita Titanium Aneurysm Clip II Mini Type No.8793/42 Sugita Titanium Aneurysm Clip II Mini Type No.8893/42 Sugita Titanium Aneurysm Clip II Mini Type No.8993/42 Sugita Titanium Aneurysm Clip II Mini Type No.9593/42 Sugita Titanium Aneurysm Clip II Mini Type No.9693/42 Sugita Titanium Aneurysm Clip II Mini Type No.9793/42 Sugita Titanium Aneurysm Clip II Mini Type No.9893/42 Sugita Titanium Aneurysm Clip II Mini Type No.9993/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.10793/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.10893/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.10993/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.14193/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.14293/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.14393/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.14493/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.14593/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.14693/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.14993/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.2693/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.2793/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.2893/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.2993/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.3093/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.3193/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.3293/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.3393/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.3493/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.3593/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.3693/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.3793/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.3893/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.3993/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.4093/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.4193/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.4293/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.4393/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.4493/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.4593/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.4693/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.7493/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.7593/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.7693/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.7793/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.7893/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.7993/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.F193/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.F1193/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.F1293/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.F1393/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.F1493/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.F293/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.F693/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.F793/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.F893/42 Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.F993/42 Sugita Titanium Aneurysm Clip II Standard Type No.193/42 Sugita Titanium Aneurysm Clip II Standard Type No.1093/42 Sugita Titanium Aneurysm Clip II Standard Type No.1193/42 Sugita Titanium Aneurysm Clip II Standard Type No.1293/42 Sugita Titanium Aneurysm Clip II Standard Type No.1393/42 Sugita Titanium Aneurysm Clip II Standard Type No.1493/42 Sugita Titanium Aneurysm Clip II Standard Type No.1593/42 Sugita Titanium Aneurysm Clip II Standard Type No.1693/42 Sugita Titanium Aneurysm Clip II Standard Type No.1793/42 Sugita Titanium Aneurysm Clip II Standard Type No.1893/42 Sugita Titanium Aneurysm Clip II Standard Type No.19A93/42 Sugita Titanium Aneurysm Clip II Standard Type No.293/42 Sugita Titanium Aneurysm Clip II Standard Type No.2093/42 Sugita Titanium Aneurysm Clip II Standard Type No.2193/42 Sugita Titanium Aneurysm Clip II Standard Type No.2293/42 Sugita Titanium Aneurysm Clip II Standard Type No.2393/42 Sugita Titanium Aneurysm Clip II Standard Type No.2493/42 Sugita Titanium Aneurysm Clip II Standard Type No.2593/42 Sugita Titanium Aneurysm Clip II Standard Type No.393/42 Sugita Titanium Aneurysm Clip II Standard Type No.493/42 Sugita Titanium Aneurysm Clip II Standard Type No.4793/42 Sugita Titanium Aneurysm Clip II Standard Type No.4893/42 Sugita Titanium Aneurysm Clip II Standard Type No.4993/42 Sugita Titanium Aneurysm Clip II Standard Type No.4B93/42 Sugita Titanium Aneurysm Clip II Standard Type No.593/42 Sugita Titanium Aneurysm Clip II Standard Type No.5093/42 Sugita Titanium Aneurysm Clip II Standard Type No.693/42 Sugita Titanium Aneurysm Clip II Standard Type No.6093/42 Sugita Titanium Aneurysm Clip II Standard Type No.6193/42 Sugita Titanium Aneurysm Clip II Standard Type No.6293/42 Sugita Titanium Aneurysm Clip II Standard Type No.6393/42 Sugita Titanium Aneurysm Clip II Standard Type No.6593/42 Sugita Titanium Aneurysm Clip II Standard Type No.6693/42 Sugita Titanium Aneurysm Clip II Standard Type No.6993/42 Sugita Titanium Aneurysm Clip II Standard Type No.793/42 Sugita Titanium Aneurysm Clip II Standard Type No.7393/42 Sugita Titanium Aneurysm Clip II Standard Type No.893/42 Sugita Titanium Aneurysm Clip II Standard Type No.8B93/42 Sugita Titanium Aneurysm Clip II Standard Type No.993/42 Sugita Titanium Aneurysm Clip II Standard Type No.C193/42 Sugita Titanium Aneurysm Clip II Standard Type No.C293/42 Sugita Titanium Aneurysm Clip II Standard Type No.C393/42 Sugita Titanium Aneurysm Clip II Temporary Mini Type No.564 refs Sugita Titanium Aneurysm Clip II Temporary Mini Type No.5793/42 Sugita Titanium Aneurysm Clip II Temporary Mini Type No.5893/42 Sugita Titanium Aneurysm Clip II Temporary Standard Type No.5193/42 Sugita Titanium Aneurysm Clip II Temporary Standard Type No.5293/42 Sugita Titanium Aneurysm Clip II Temporary Standard Type No.5393/42 Sugita Titanium Aneurysm Clip II Temporary Standard Type No.5493/42 Sugita Titanium Aneurysm Clip II Temporary Standard Type No.5593/42 Sugita Titanium Clip II Applier, 15°Angled for Long Clips3 refs Sugita Titanium Clip II Remover, 30°Angled for Mini Clips3 refs	III MDR, 93/42	EUDAMED record Report an error
Patient positioning instruments - hardware accessories	Z12011280	100 cm Carbon Fiber Extension II3 refs 100 mm Pad for Armboard3 refs 110 mm Mizuho Original Pad for 122 cm Carbon Fiber Extension3 refs 110 mm Pad for Narrow Head Section3 refs 110 mm Pad for Table Side Extension3 refs 45 others 1602 X-Ray Top Set3 refs 3008 Head Extension3 refs 50 mm Pad for Imaging Armboard3 refs 70 mm Pads for Knee Rests3 refs Adapter for Carbon Fiber Extension Adjustable Body Support (NC)3 refs Aluminium Armboard2 refs Arm for Head Rest & Face Rest3 refs Arm Shield with Pad (130 mm)3 refs Arm Strap2 refs ARM SURGERY BOARD SINGLE SIDE RAIL MOUNT WITH SUPPORT ROD3 refs Back Section Board Attachment for Pediatric3 refs Back Section Board Short3 refs Bar Clamp3 refs Basal Frame/Semi-circular Frame3 refs Body Strap (1700 mm)2 refs Boot Pad for Levitator Stirrup II, Fin Type, Left Leg3 refs Cervical Spine Frame3 refs Digital Radiographic Table Top for Leg-side Reversal Adapter3 refs Digital Radiographic Table Tops Fixed Type for Head Extension (240 mm)3 refs Digital Radiographic Table Tops Fixed Type for Seat Extension (300 mm)3 refs DIGITAL X-RAY TOP SET 35033 refs Four-point Spinal Frame3 refs Head Extension II3 refs Head Supporter3 refs Headside Rail3 refs Horseshoe Head Rest, L3 refs IVR Armboard Kidney Bridge with Pad3 refs KNEE CRUTCHES (PR) NO CLAMPS3 refs KUB BOARD 6500WARNING SPACERS REQUIRED IF USING METAL TRAY3 refs Leg Extension for 5700 Series3 refs OB Hand Grips2 refs Pad for Radiolucent Head Extension for VACB3 refs Pad for Shoulder Positioner3 refs Radiographic Table Top for MOT-5602SRMB Shoulder Supports3 refs Side Rail Adaptor II, Long for Carbon Fiber Board3 refs Side Rail Adaptor, Long for Carbon Fiber Board3 refs Side Rail Extension2 refs SUSANO Pad for Seat Extension (300 mm)3 refs Transfer Board II (Rail Fixation Type) UNIVERSAL CASSETTE HOLDER3 refs Upper Arm Support II (NC)3 refs Wrist Strap (240 mm)3 refs	I MDR	EUDAMED record Report an error
Operating tables	Z12011202	3503 EZ Slide 3603 UltraSlide Operating Table MOT-VS6003 refs MOT-VE100Da Operating Table MOT-VE1003 refs MOT-VS500DKa Operating Table MOT-VS5003 refs MOT-VS700UIa Operating Table MOT-VS7003 refs 10 others Operating Table 6702 HERCULES MOT-6702, 6702X, 6702 HERCULES3 refs Operating Table ELITE 6302 MOT-6302, MOT-6302X, ELITE 63023 refs Operating Table MOS-1302B3 refs Operating Table MOT-3602 MOT-3602, MOT-3602X3 refs Operating Table MOT-5602BW3 refs Operating Table MST-7300B, Operating Table MST-7300BX3 refs Operating Table MST-7300BX-MR-T Intraoperative Diagnostic Operating Table System, Operating Table MST-7300BX-MR-NP Intraoperative Diagnostic Operating Table System, Operating Table MST-7300BX-MR-N Intraoperative Diagnostic Operating Table System3 refs Operating Table VACB-3006B, Operating Table VACB-3006B Type150S, 3008 Clarity3 refs Universal Operating Table SPL-331 Model SPL-331 Universal Operating Table Operating Table MOT-3502 MOT-3502, MOT-3502X3 refs (no longer marketed)	I MDR	EUDAMED record Report an error
Patient positioning instruments - other	Z12011299	Adjustable Hand Rest with Dome Screw3 refs Body Strap (2500 mm)2 refs MRI Base Table 73003 refs Sugita Aneurysm Clip Organizational Tray A. (Clip Tray Basket Not Applier case)3 refs	I MDR	EUDAMED record Report an error
Medical support equipment - accessories	V0880	Anesthesia Frame with Clamp3 refs Anesthesia Screen L Type with Clamp3 refs LATERAL CASSETTE HOLDER3 refs	I MDR	EUDAMED record Report an error

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