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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 16 of 19

Device	Model / Reference	Registries	Class	Status
Gladius MG14 PV	PP14R203P	EUDAMED	Class IIa	Active
ASAHI Veloute Microcatheter	VEL105-16S	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 4.5cm, Short Tip, Side Hole	HW80JL452P10001	EUDAMED	Class III	Active
ASAHI Veloute Microcatheter	VEL125-16S	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JR40-2-X100	EUDAMED	Class III	Active
Gladius MG18 PV ES	PP18R304P	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JL45-2-X100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 5.0cm, Side Hole	HW70JL502P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Champ 2.0cm	HW60CP200P10000	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Miracle 6 300cm	AG14M360	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Amplatz Right 1.0cm, Side Hole	HW70AR102P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Short Amplatz Left 2.0cm	HW80AL200P10002	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Champ 1.0cm	HW80CP100P10000	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 6.5 Fr, Judkins Right 3.5cm, Short Tip, 100cm	G6JR35-0-L100S	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6JR30-0-X100S	EUDAMED	Class III	Active
Gladius MG14 PV ES	PP14R204S	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7HS00-2-X100	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8CP05-0-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Judkins Left 4.5cm, Short Tip	HW60JL450P10001	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Power Backup 3.5cm, Side Hole	HW60PB352P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Super Power Backup 3.0cm	HW80SP300P10000	EUDAMED	Class III	Active
ASAHI Tellus Microcatheter	TLS105-16Y	EUDAMED	Class IIa	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Judkins Right 5.0cm, Short Tip, 100cm	G7JR50-0-L100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 5.0cm, Short Tip	HW80JL500P10001	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7CR40-2-X100	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire Astato XS 40	PAGHW143094	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7FR30-0-X100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Short Amplatz Left 2.0cm, Side Hole	HW80AL202P10002	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Amplatz Left 1.5cm	HW60AL150P09000	EUDAMED	Class III	Active
Astato XS 40	PAGHW143394	EUDAMED	Class IIa	Active
ASAHI PTCA Guide Wire Fielder XT-R	APW14R005S	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8JR30-2-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire MIRACLEbros 3	AG14M050	EUDAMED	Class III	Active
ASAHI Gaia PV	PHW18R302S	EUDAMED	Class IIa	Active
ASAHI NEO'S PTCA Guide Wire ROUTE J	AGH147000J	EUDAMED	Class III	Active
ASAHI Silverway	SJ1535N30S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, RCA Backup 0.75cm	HW70RB070P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Multi Purpose 02, Side Hole	HW70MP022P10000	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-6A80	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-7S	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Super Power Backup 4.0, 100cm	G8SP40-0-L100	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-7AH	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Conquest	AG143090	EUDAMED	Class III	Active
ASAHI Tellus	TLS105-16AY	EUDAMED	Class IIa	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Amplatz Left 1.0, 100cm	G7AL10-0-L100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Shepherd's Crook 3.5cm, Side Hole	HW80SA352P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Short Amplatz Left 1.5cm, Side Hole	HW60AL152P09002	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Miracle 3 300cm	AG14M350	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Right 4.0cm	HW80JR400P10000	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire ASAHI Gladius MG14 PV ES	PP14R204P	EUDAMED	Class IIa	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