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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 6 of 19

Device	Model / Reference	Registries	Class	Status
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Power Backup 4.0cm, Side Hole	HW80PB402P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JR35-2-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Super Power Backup 3.5cm, Side Hole	HW70SP352P09000	EUDAMED	Class III	Active
ASAHI CHIKAI black 200cm Round curve	WAIN-CKI-200-BS	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Multi Purpose 01, Side Hole	HW80MP012P10000	EUDAMED	Class III	Active
ASAHI PTCA GUIDE WIRE ASAHI MIRACLEbros 12 180cm	AG14M070	EUDAMEDFDA UDI	Class III	Active
ASAHI PTCA Guide Wire ASAHI SION blue ES 300cm J	AHW14R317J	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 6.5 Fr, Amplatz Left 2.0, Short Tip, 100cm	G6AL20-0-L100S	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JL45-2-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Power Backup 3.0cm	HW80PB300P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7CL40-2-X100	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Fielder FC 180cm J	AGP140001J	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Super Power Backup 4.0cm, Side Hole	HW70SP402P09000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8FL30-0-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Champ 3.0cm	HW80CP300P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Short Amplatz Left 1.5cm	HW80AL150P10002	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Miracle 4.5 300cm J	AG14M345J	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JR50-2-X100	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire ASAHI Gladius	PPW14R100S	EUDAMEDFDA 510(k)	Class IIa	Active
ASAHI Gaia Third	AHW14R011S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Super Power Backup 3.5cm, Side Hole	HW60SP352P09000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Champ 3.5cm	HW60CP350P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Amplatz Right 2.0cm	HW80AR200P10000	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire ASAHI SION 300cm	AHW14R301S	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Miracle 3 J	AG14M050J	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 3.5cm, Side Hole	HW70JL352P10000	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Amplatz Left 1.5, Short Tip, 100cm	G7AL15-0-L100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Multi Purpose 01, Side Hole	HW70MP012P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6FR50-2-X100	EUDAMED	Class III	Active
Gladius	PPW14R300S	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Power Backup 3.5cm	HW80PB350P10000	EUDAMED	Class III	Active
ASAHI PTCA GUIDE WIRE ASAHI MIRACLEbros 4.5 180cm	AG14M045	EUDAMEDFDA UDI	Class III	Active
ASAHI PTCA Guide Wire, 0.014", ASAHI SUOH 03 300cm	AHW14R313S	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 6.5 Fr, Power Backup 3.5, 100cm	G6PB35-0-L100	EUDAMED	Class III	Active
ASAHI PTCA GUIDE WIRE ASAHI MIRACLEbros 3 300cm	AG14M350	EUDAMEDFDA UDI	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Short Amplatz Left 1.0cm	HW60AL100P10002	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Power Backup 4.0cm	HW70PB400P09000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JR30-2-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire PROWATERflex 300cm	AGH147300	EUDAMEDFDA UDI	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8FR50-2-X100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Judkins Left 3.0cm, Side Hole	HW60JL302P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JR35-0-X100S	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 6.5 Fr, Judkins Left 4.0cm, Short Tip, 100cm	G6JL40-0-L100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Multi Purpose 01, Side Hole	HW60MP012P10000	EUDAMED	Class III	Active
ASAHI Tellus Microcatheter	TLS125-16SSL	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7FR30-0-X100	EUDAMED	Class III	Active
Astato 30	PAGH18M371	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JL35-0-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Miracle 6 J	AG14M060J	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Short Amplatz Left 0.75cm	HW70AL070P09002	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

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FDA Establishments (1)

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

Asahi Intecc Co., Ltd. US