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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 9 of 19

Device	Model / Reference	Registries	Class	Status
ASAHI Veloute Microcatheter	VEL105-16AY	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Judkins Left 4.0cm, Side Hole	HW70JL402P09000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6FR50-2-X100S	EUDAMED	Class III	Active
ASAHI Tellus Microcatheter	TLS105-16K	EUDAMED	Class IIa	Active
ASAHI PTCA Guide Wire Fielder XT-R 300cm	APW14R305S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Judkins Left 3.0cm, Short Tip	HW60JL300P10001	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8FR40-2-X100	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8JR45-0-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Power Backup 3.5cm	HW60PB350P09000	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Judkins Left 5.0cm, 100cm	G7JL50-0-L100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 3.5cm, Side Hole	HW80JL352P10000	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Fielder XT-A	APW14R009S	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 6.5 Fr, Power Backup 4.0, 100cm	G6PB40-0-L100	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Miracle 3 300cm J	AG14M350J	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Conquest Pro J	AGH143090J	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Amplatz Left 1.0, 100cm	G8AL10-0-L100	EUDAMED	Class III	Active
Gladius MG18 PV ES	PP18R204P	EUDAMED	Class IIa	Active
ASAHI Veloute Microcatheter	VEL125-16AK	EUDAMED	Class IIa	Active
ASAHI Peripheral Guide Wire Treasure Floppy 300cm	PAGH18M372	EUDAMED	Class IIa	Active
ASAHI Corsair Pro XS Microcatheter, 150cm	CSR150-21S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Hockey Stick 02, Side Hole	HW70HS022P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Short Amplatz Left 1.0cm	HW80AL100P09002	EUDAMED	Class III	Active
ASAHI Gladius MG14 ES 190cm Pre-shape	AP14R024P	EUDAMEDFDA UDI	Class III	Active
ASAHI Extension Wire Extension	AG149000	EUDAMED	Class I	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8PB35-2-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire ASAHI SION black 300cm Pre-shape	APW14R310P	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire ASAHI Gladius MG18 PV ES	PP18R204S	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 3.0cm	HW80JL300P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6SP40-0-X100	EUDAMED	Class III	Active
SheathLessPV, 6 Fr, Angle45, 55cm	W8AN45-0-V055	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JR45-2-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Champ 1.0cm	HW60CP100P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7FR40-0-X100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Special Curve 4.0cm, Side Hole	HW60SC402P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Amplatz Right 2.0cm	HW60AR200P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6AL20-2-X100	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7AL07-0-X100S	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8AR20-2-X100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, RCA Backup 1.0cm	HW80RB100P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Judkins Right 3.5cm	HW80JR350P09000	EUDAMED	Class III	Active
ASAHI Gladius EX14 200cm Straight	AP14R025S	EUDAMED	Class III	Active
ASAHI Gaia Second Pre-shape	AHW14R008P	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7SP30-2-X100	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Miracle 12	AG14M070	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Short Amplatz Left 2.0cm, Side Hole	HW60AL202P09002	EUDAMED	Class III	Active
Gladius MG18 PV ES	PP18R304S	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6CP20-0-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Shepherd's Crook 4.0cm, Side Hole	HW60SA402P10000	EUDAMED	Class III	Active
ASAHI PTCA GUIDE WIRE ASAHI MIRACLEbros 12 300cm	AG14M370	EUDAMEDFDA UDI	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7JL40-0-X100	EUDAMED	Class III	Active

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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