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ASAHI ZenyteEX PTCA GUIDING CATHETER - EUDAMED Registration 04547327078337

Access comprehensive regulatory information for ASAHI ZenyteEX PTCA GUIDING CATHETER in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 04547327078337 and manufactured by ASAHI INTECC CO., LTD. in Japan.

This page provides complete registration details including trade name (ASAHI ZenyteEX PTCA GUIDING CATHETER), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class III
04547327078337
No
ASAHI ZenyteEX PTCA GUIDING CATHETER
Trade Name: ASAHI ZenyteEX PTCA GUIDING CATHETER
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Device Description (EMDN)

CARDIAC ANGIOGRAPHY GUIDE CATHETERS

Device Classification
Risk Class
Class III
CND Nomenclatures Code
C0104010202
Trade Name
ASAHI ZenyteEX PTCA GUIDING CATHETER
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04547327078337
Basic UDI
B-04547327078337
Version Date
December 11, 2024
Manufacturer Last Update
September 17, 2021
Active Status
No
Manufacturer
Manufacturer Name
ASAHI INTECC CO., LTD.
Country
Japan
Country Type
NON_EU
Address
3-100 Akatsuki-cho Seto
Email
AI_eudamed@asahi-intecc.com
Authorized Representative
SRN
NL-AR-000000116
Country
Netherlands
Address
60 Westervoortsedijk Arnhem
Email
lst.aus.euauthrep@ul.com
Telephone
+31 70 345 8570
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Austria
Market Available
Malta:None~2024-05-26, Netherlands:None~2024-05-26, Norway:None~2024-05-26, Portugal:None~2024-05-26, Belgium:None~2024-05-26, Sweden:None~2024-05-26, Romania:None~2024-05-26, Slovenia:None~2024-05-26, Cyprus:None~2024-05-26, Ireland:None~2024-05-26, France:None~2024-05-26, Hungary:None~2024-05-26, Croatia:None~2024-05-26, Greece:None~2024-05-26, Estonia:None~2024-05-26, Denmark:None~2024-05-26, Germany:None~2024-05-26, Czechia:None~2024-05-26, Slovakia:None~2024-05-26, Liechtenstein:None~2024-05-26, Latvia:None~2024-05-26, Luxembourg:None~2024-05-26, Spain:None~2024-05-26, Lithuania:None~2024-05-26, Iceland:None~2024-05-26, Poland:None~2024-05-26, Finland:None~2024-05-26, Austria:None~2024-05-26, Bulgaria:None~2024-05-26, Italy:None~2024-05-26
Device Characteristics
Human Tissues
No
Animal Tissues
No