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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 12 of 19

Device	Model / Reference	Registries	Class	Status
ASAHI PTCA Guide Wire Grand Slam 300cm J	AG141302J	EUDAMED	Class III	Active
SheathLessPV, 6 Fr, Angle45, 120cm	W8AN45-0-V120	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Judkins Left 3.5cm, Short Tip	HW60JL350P10001	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Judkins Left 4.5cm, Side Hole	HW60JL452P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 4.0cm, Short Tip	HW70JL400P10001	EUDAMED	Class III	Active
Astato XS 20	PAGH143092	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Internal Mammary, Side Hole	HW80IM002P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8FR45-0-X100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Judkins Left 4.0cm	HW70JL400P09000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7AR10-2-X100	EUDAMED	Class III	Active
ASAHI Gladius MG14 ES 190cm Straight	AP14R024S	EUDAMEDFDA UDI	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Judkins Left 3.0cm, Short Tip, Side Hole	HW60JL302P10001	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Judkins Left 4.0cm, 100cm	G8JL40-0-L100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Right 4.5cm	HW80JR450P10000	EUDAMED	Class III	Active
ASAHI Corsair Armet Microcatheter, 135cm	WCSAR135-14N	EUDAMED	Class IIa	Active
ASAHI PTCA Guide Wire ASAHI SION black 190cm J	APW14R010J	EUDAMED	Class III	Active
Halberd	PHW14R101S	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7AL20-0-X100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Amplatz Left 0. 75cm	HW60AL070P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6CR40-2-X100	EUDAMED	Class III	Active
ASAHI Gaia First 300cm	AHW14R307S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Multi Purpose 01	HW70MP010P10000	EUDAMED	Class III	Active
ASAHI Tellus	TLS105-16S	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Judkins Left 4.0cm, Side Hole	HW60JL402P09000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8JL50-2-X100S	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire, 0.014", ASAHI SUOH 03 190cm	AHW14R013S	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8JR35-2-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Miracle 4.5	AG14M045	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire MIRACLEbros 4.5	AG14M045	EUDAMED	Class III	Active
ASAHI CHIKAI 300cm Round curve	WAIN-CKI-300-RC	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JL40-2-X100S	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6CL40-2-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire MIRACLEbros 12	AG14M070	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Amplatz Right 1.0cm, Side Hole	HW80AR102P10000	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Hockey Stick, 100cm	G7HS00-0-L100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, RCA Backup 1.0cm	HW70RB100P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7HS00-0-X100	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8CL45-2-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Miracle 6	AG14M060	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire ASAHI Gladius MG14 PV	PP14R303P	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Power Backup 3.5cm, Side Hole	HW70PB352P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7CP30-0-X100	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire Regalia XS 1.0 300cm	PAGP140300	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7SC40-0-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Champ 3.0cm	HW70CP300P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Right 4.0cm	HW70JR400P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Power Backup 4.0cm	HW80PB400P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Amplatz Left 1.0cm	HW60AL100P09000	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Gland Slam 300cm J	AG141302J	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Champ 3.25cm	HW80CP320P10000	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

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