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ASAHI INTECC CO., LTD.

Japan·JP-MF-000010199

Last updated September 17, 2026

Information

Country: Japan
Address: 3-100 Akatsuki-cho, Seto, Japan
Website: asahi-intecc.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Yasuyuki Kawahara
EUDAMED SRN: JP-MF-000010199
FDA FEI Number: 3003775027
DUNS Number: —

Catalogue (917)

Page 13 of 19

Device	Model / Reference	Registries	Class	Status
SheathLessPV, 6 Fr, Angle45, 90cm	W8AN45-0-V090	EUDAMED	Class IIa	Active
ASAHI PTCA Guide Wire, 0.014", ASAHI SUOH 03 300cm Pre-shape	AHW14R313P	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8SA35-2-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Amplatz Left 1.5cm	HW70AL150P09000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Amplatz Left 2.0cm	HW60AL200P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8FR45-2-X100	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6CP30-0-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Conquest Pro	AGH143090	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire ASAHI Gladius MG14 PV ES	PP14R004S	EUDAMED	Class IIa	Active
SheathLess Eaucath PTCA Guiding Catheter, 6.5 Fr, Amplatz Left 0.75, Short Tip, 100cm	G6AL07-0-L100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Judkins Left 4.0cm	HW80JL400P09000	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire ASAHI SION blue 300cm	AHW14R304S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Super Power Backup 3.75cm	HW80SP370P10000	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-5SD110	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8JL30-0-X100S	EUDAMED	Class III	Active
ASAHI CHIKAI 008 200cm	WAIN-CKI-008-200	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Judkins Left 3.5cm, Short Tip, 100cm	G7JL35-0-L100S	EUDAMED	Class III	Active
ASAHI Masters PARKWAY HF KIT Guide Wire Pre-loaded Microcatheter	WMST125-27HFKM	EUDAMED	Class IIa	Active
SheathLess Eaucath PTCA Guiding Catheter, 6.5 Fr, Judkins Right 5.0cm, Short Tip, 100cm	G6JR50-0-L100S	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire ASAHI SION blue 300cm Pre-shape	AHW14R304P	EUDAMEDFDA UDI	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8FR30-0-X100	EUDAMED	Class III	Active
Gladius	PPW14R100P	EUDAMEDFDA UDI	Class IIa	Active
Gladius MG14 PV ES	PP14R004P	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JR45-2-X100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 4.0cm	HW80JL400P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Short Amplatz Left 1.5cm, Side Hole	HW70AL152P10002	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Route	AGH147000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Short Amplatz Left 1.5cm, Side Hole	HW80AL152P10002	EUDAMED	Class III	Active
ASAHI Tellus	TLS125-16AS	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Amplatz Left 1.5cm, Side Hole	HW60AL152P10000	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 6.5 Fr, Special Curve 4.0, 100cm	G6SC40-0-L100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Fielder FC 300cm	AGP140301	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8IM00-0-X100	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 6.5 Fr, Multi Purpose 2.0, 100cm	G6MP20-0-L100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Short Amplatz Left 1.5cm	HW70AL150P10002	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Judkins Left 4.0cm, Short Tip, Side Hole	HW70JL402P09001	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Right 3.5cm	HW70JR350P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Judkins Left 3.5cm	HW70JL350P09000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Short Amplatz Left 2.0cm, Side Hole	HW70AL202P10002	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Route 300cm	AGH147300	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Super Power Backup 4.0cm, Side Hole	HW80SP402P09000	EUDAMED	Class III	Active
Masters PARKWAY SOFT	WMST45A-18PWSSF	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6FL40-0-X100S	EUDAMED	Class III	Active
ASAHI Tellus Microcatheter	TLS150-16AY	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6FL50-0-X100S	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-7S80	EUDAMED	Class III	Active
ASAHI Silverway	SJ1535N18S	EUDAMED	Class III	Active
ASAHI Silverway	SJ3035N30S	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Super Power Backup 3.0, 100cm	G7SP30-0-L100	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6CP05-0-X100	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Asahi Intecc Co., Ltd. US