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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 14 of 19

Device	Model / Reference	Registries	Class	Status
ASAHI Gladius EX14 200cm Pre-shape	AP14R025P	EUDAMED	Class III	Active
Masters PARKWAY HF	WMST125-27HF	EUDAMED	Class IIa	Active
ASAHI Corsair Armet Microcatheter, 60cm	WCSAR060-14N	EUDAMED	Class IIa	Active
ASAHI Veloute	VEL125-16Y	EUDAMED	Class IIa	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7JL30-2-X100	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-8SL	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Fielder XT 300cm	AGP140302	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Fielder FC 300cm J	AGP140301J	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7FR40-2-X100S	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-6AL	EUDAMED	Class III	Active
ASAHI Tellus Microcatheter	TLS125-16Y	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Amplatz Left 1.0cm	HW60AL100P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Judkins Left 3.5cm	HW80JL350P09000	EUDAMED	Class III	Active
Halberd	PHW18R301P	EUDAMED	Class IIa	Active
ASAHI PTCA GUIDE WIRE FIELDER FC 300cm J	AGP140301J	EUDAMEDFDA UDI	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Hockey Stick 02, Side Hole	HW80HS022P10000	EUDAMED	Class III	Active
ASAHI PTCA GUIDE WIRE ASAHI CONFIANZA PRO 300cm	AGH143390	EUDAMEDFDA UDI	Class III	Active
ASAHI PTCA Guide Wire PROWATERflex J	AGH147000J	EUDAMED	Class III	Active
The ASAHI Tornus 2.6 Fr〔88 Flex〕Support Catheter	AT35135	EUDAMED	Class III	Active
ASAHI PTCA GUIDE WIRE FIELDER FC 180cm J	AGP140001J	EUDAMEDFDA UDI	Class III	Active
ASAHI Peripheral Guide Wire ASAHI Gladius MG14 PV	PP14R003S	EUDAMED	Class IIa	Active
ASAHI Veloute Microcatheter	VEL150-16AY	EUDAMED	Class IIa	Active
ASAHI Peripheral Guide Wire ASAHI Halberd	PHW14R201S	EUDAMED	Class IIa	Active
ASAHI PTCA Guide Wire Miracle 12 J	AG14M070J	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Champ 2.0cm	HW80CP200P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7SP37-0-X100	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-6SDL	EUDAMED	Class III	Active
Gladius	PPW18R100S	EUDAMED	Class IIa	Active
SheathLessPV, 6 Fr, Standard, Straight, 55cm	W8ST00-0-V055	EUDAMED	Class IIa	Active
ASAHI PTCA GUIDE WIRE ASAHI CONFIANZA PRO 12 180cm	AGH143091	EUDAMEDFDA UDI	Class III	Active
ASAHI CHIKAI black 14 soft tip	AIN-CKI-200-B-SFT	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7JR50-0-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Judkins Right 4.0cm	HW70JR400P09000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Special Curve 4.0cm, Side Hole	HW70SC402P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8AL15-0-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire, 0.014", ASAHI SUOH 03 190cm Pre-shape	AHW14R013P	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Amplatz Right 2.0cm, Side Hole	HW70AR202P10000	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire ASAHI Gladius	PPW18R200P	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Short Amplatz Left 2.0cm	HW70AL200P09002	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Multi Purpose 2.0, 100cm	G7MP20-0-L100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Fielder J	AGP140000J	EUDAMED	Class III	Active
ASAHI Gaia First Pre-shape	AHW14R007P	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Grand Slam 300cm	AG141302	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Miracle 3	AG14M050	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7JR40-2-X100	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7CL30-2-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire ASAHI RG3	AHW10S302S	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8SP30-2-X100	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire Regalia XS 1.0	PAGP140000	EUDAMED	Class IIa	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Power Backup 4.0cm, Side Hole	HW70PB402P10000	EUDAMED	Class III	Active

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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