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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 17 of 19

Device	Model / Reference	Registries	Class	Status
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8FR50-2-X100	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7AL07-2-X100S	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6FL40-0-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire MIRACLEbros 6 300cm	AG14M360	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Fielder FC	AGP140001	EUDAMED	Class III	Active
Gladius	PPW18R300S	EUDAMED	Class IIa	Active
ASAHI Peripheral Guide Wire ASAHI Halberd	PHW14R201P	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Short Amplatz Left 1.0cm	HW80AL100P10002	EUDAMED	Class III	Active
Masters PARKWAY SOFT	WMST105-18PWSF	EUDAMED	Class IIa	Active
ASAHI Peripheral Vascular Guide Wire ASAHI Meister 16, 0.016", 180cm, Double angle	WAMS-180-16WA	EUDAMED	Class IIa	Active
ASAHI Peripheral Vascular Guide Wire ASAHI CHIKAI V 180cm	WCKV180-14	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8CL40-0-X100	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire ASAHI Gladius MG18 PV ES	PP18R004P	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8JL30-2-X100	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-4ADL	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7SP40-2-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Champ 2.75cm	HW80CP270P10000	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire ASAHI SION black 190cm	APW14R010S	EUDAMED	Class III	Active
ASAHI Corsair Microcatheter	CSW150-26N	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6FL35-0-X100S	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire ULTIMATEbros 3	AHW14S003S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Power Backup 3.0cm, Side Hole	HW60PB302P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Short Amplatz Left 1.5cm	HW70AL150P09002	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6AR10-2-X100S	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7FR35-0-X100	EUDAMED	Class III	Active
ASAHI PTCA GUIDE WIRE PROWATERflex 180cm	AGH147000	EUDAMEDFDA UDI	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8FL45-2-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Amplatz Left 1.5cm, Side Hole	HW80AL152P10000	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Super Power Backup 4.0, 100cm	G7SP40-0-L100	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Judkins Right 5.0cm, 100cm	G7JR50-0-L100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Power Backup 3.0cm, Side Hole	HW70PB302P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Amplatz Left 1.5cm	HW70AL150P10000	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Soft	AG141000	EUDAMED	Class III	Active
ASAHI Veloute	VEL105-16AS	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Judkins Left 5.0cm, Short Tip, Side Hole	HW60JL502P10001	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire ASAHI SION blue ES 300cm Pre-shape	AHW14R317P	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8FL35-2-X100S	EUDAMED	Class III	Active
ASAHI Gladius EX14 300cm Pre-shape	AP14R325P	EUDAMED	Class III	Active
ASAHI PTCA GUIDE WIRE ASAHI MIRACLEbros 6 300cm	AG14M360	EUDAMEDFDA UDI	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Multi Purpose 02	HW70MP020P10000	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Conquest Pro	AGH143090	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7FR50-0-X100S	EUDAMED	Class III	Active
ASAHI Silverway	SJ3035N18S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 3.0cm	HW70JL300P10000	EUDAMED	Class III	Active
ASAHI Tellus Microcatheter	TLS105-16AK	EUDAMED	Class IIa	Active
ASAHI PTCA Guide Wire Fielder XT-A 300cm	APW14R309S	EUDAMED	Class III	Active
ASAHI Tellus Microcatheter	TLS125-16SLK	EUDAMED	Class IIa	Active
ASAHI NEO'S PTCA Guide Wire Miracle 3	AG14M050	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Champ 2.5cm	HW70CP250P10000	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Soft 300cm J	AG141300J	EUDAMED	Class III	Active

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Emergo Europe B.V. NL

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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