BEUDAMED

EU Manufacturer 🇯🇵 Japan Active

ASAHI INTECC CO., LTD.

SRN: JP-MF-000010199 · 3-100 Akatsuki-cho, 489-0071 Seto, Japan

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Basic UDI-DIs

1371

Total Devices

1371

On Market

619

Off Market

752

Certificates

Valid

Expiring < 6mo

Countries

Watch ASAHI INTECC CO., LTD. for changes

We'll email you when it registers new devices, or a certificate is issued or withdrawn.

Basic Information

Address: 3-100 Akatsuki-cho, 489-0071 Seto, Japan
Email: [email protected]

Regulatory Overview

Regulation

Eu Mdd 1371

Classification

Eu Md Class 3 1237

Eu Md Class 2a 132

Eu Md Class 1 2

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Expiry Date
MDD Annex II (excluding section 4)	2107788DE01	DEKRA Certification B.V.	Aug 12, 2022
MDD Annex II Section 4	2107788CE01	DEKRA Certification B.V.	Aug 12, 2022
MDD Annex II (excluding section 4)	2107788DE14	DEKRA Certification B.V.	Oct 01, 2022
MDD Annex II Section 4	2107788CE16	DEKRA Certification B.V.	Oct 01, 2022
MDD Annex II Section 4	2107788CE21	DEKRA Certification B.V.	Oct 06, 2022
MDD Annex II Section 4	2107788CE27	DEKRA Certification B.V.	Dec 31, 2022
MDD Annex II Section 4	2107788CE11	DEKRA Certification B.V.	Feb 01, 2023
MDD Annex II (excluding section 4)	2107788DE18	DEKRA Certification B.V.	Apr 01, 2023
MDD Annex II Section 4	2107788CE22	DEKRA Certification B.V.	Apr 01, 2023
MDD Annex II Section 4	2107788CE17	DEKRA Certification B.V.	Apr 19, 2023
MDD Annex II (excluding section 4)	2107788DE06	DEKRA Certification B.V.	Apr 22, 2023
MDD Annex II Section 4	2107788CE06	DEKRA Certification B.V.	Apr 22, 2023
MDD Annex II (excluding section 4)	2107788DE22	DEKRA Certification B.V.	May 09, 2023
MDD Annex II Section 4	2107788CE28	DEKRA Certification B.V.	May 09, 2023
MDD Annex II Section 4	2107788CE29	DEKRA Certification B.V.	Jun 25, 2023
MDD Annex II (excluding section 4)	2107788DE19	DEKRA Certification B.V.	Jul 05, 2023
MDD Annex II Section 4	2107788CE23	DEKRA Certification B.V.	Jul 05, 2023
MDD Annex II Section 4	2107788CE03	DEKRA Certification B.V.	Sep 01, 2023
MDD Annex II (excluding section 4)	2107788DE03	DEKRA Certification B.V.	Sep 01, 2023
MDD Annex II (excluding section 4)	2107788DE10	DEKRA Certification B.V.	Mar 15, 2024
MDD Annex II Section 4	2107788CE12	DEKRA Certification B.V.	Mar 15, 2024
MDD Annex II (excluding section 4)	2107788DE20	DEKRA Certification B.V.	May 01, 2024
MDD Annex II Section 4	2107788CE24	DEKRA Certification B.V.	May 01, 2024
MDD Annex II (excluding section 4)	2107788DE15	DEKRA Certification B.V.	May 16, 2024
MDD Annex II Section 4	2107788CE18	DEKRA Certification B.V.	May 16, 2024
MDD Annex II (excluding section 4)	2107788DE11	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2107788CE13	DEKRA Certification B.V.	May 26, 2024
MDD Annex II (excluding section 4)	2107788DE23	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2107788CE30	DEKRA Certification B.V.	May 26, 2024
MDD Annex II (excluding section 4)	2107788DE17	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2107788CE20	DEKRA Certification B.V.	May 26, 2024
MDD Annex II (excluding section 4)	2107788DE09	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2107788CE10	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2107788CE09	DEKRA Certification B.V.	May 26, 2024
MDD Annex II (excluding section 4)	2107788DE24	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2107788CE31	DEKRA Certification B.V.	May 26, 2024
MDD Annex II (excluding section 4)	2107788DE21	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2107788CE25	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2107788CE26	DEKRA Certification B.V.	May 26, 2024
MDD Annex II (excluding section 4)	2107788DE13	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2107788CE15	DEKRA Certification B.V.	May 26, 2024

Market Presence

Devices from this manufacturer are available in 30 countries across Europe.

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia

Device Portfolio

Name	Regulation	Classification	Market Status	Certificates
ASAHI CHIKAI 008 200cm	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI 10 200cm	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI 10 300cm	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI 200cm	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI 200cm Round curve	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI 300cm	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI 300cm Round curve	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI X 010	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI black 14 soft tip	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI black 18 200cm Round curve	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI black 18 soft tip	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI black 200cm 90°	EU MDD	Eu Md Class 3	Off Market	2
ASAHI CHIKAI black 200cm Round curve	EU MDD	Eu Md Class 3	Off Market	2
ASAHI Caravel Microcatheter,2.6Fr, Straight-Tip, 135cm	EU MDD	Eu Md Class 3	On Market	2
ASAHI Caravel Microcatheter,2.6Fr, Straight-Tip, 150cm	EU MDD	Eu Md Class 3	On Market	2
ASAHI Corsair Armet Microcatheter, 135cm	EU MDD	Eu Md Class 2a	Off Market	1
ASAHI Corsair Armet Microcatheter, 150cm	EU MDD	Eu Md Class 2a	Off Market	1
ASAHI Corsair Armet Microcatheter, 60cm	EU MDD	Eu Md Class 2a	Off Market	1
ASAHI Corsair Armet Microcatheter, 90cm	EU MDD	Eu Md Class 2a	Off Market	1
ASAHI Corsair Microcatheter	EU MDD	Eu Md Class 3	On Market	2
ASAHI Corsair Microcatheter	EU MDD	Eu Md Class 3	On Market	2
ASAHI Corsair Pro　Microcatheter, 135cm	EU MDD	Eu Md Class 3	On Market	2
ASAHI Corsair Pro　Microcatheter, 150cm	EU MDD	Eu Md Class 3	On Market	2
ASAHI Extension Wire Extension	EU MDD	Eu Md Class 1	On Market	1
ASAHI Extension Wire Extension 165cm	EU MDD	Eu Md Class 1	On Market	1
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	EU MDD	Eu Md Class 3	Off Market	2

View all 1371 devices →

PRRC

Name

Yasuyuki Kawahara

Country

🇯🇵 Japan

Authorized Representative

Name

Emergo Europe B.V.

Country

🇳🇱 Netherlands

Importer

Name

Arseus Medical Group nv

Country

🇧🇪 Belgium

Notified Bodies

DEKRA Certification B.V.

41 certs

Competent Authority

Name

Ministry of Health, Welfare and Sports

Country

🇳🇱 Netherlands

More about this competent authority →

PSUR Report

Search FDA adverse events and recalls name-matched to ASAHI INTECC CO., LTD. — useful for PSUR and supplier checks.

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