ASAHI ZenyteEX PTCA GUIDING CATHETER
- Risk class
- Class III
- CND nomenclatures code
- C0104010202
- Trade name
- ASAHI ZenyteEX PTCA GUIDING CATHETER
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 04547327079280
- Basic UDI
- B-04547327079280
- Version date
- December 11, 2024
- Manufacturer last update
- September 17, 2021
- Active status
- No
- Manufacturer name
- ASAHI INTECC CO., LTD.
- Country
- Japan
- Country type
- NON_EU
- Address
- 3-100 Akatsuki-cho Seto
- AI_eudamed@asahi-intecc.com
- SRN
- NL-AR-000000116
- Country
- Netherlands
- Address
- 60 Westervoortsedijk Arnhem
- lst.aus.euauthrep@ul.com
- Telephone
- +31 70 345 8570
- 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
- Human tissues
- No
- Animal tissues
- No
CARDIAC ANGIOGRAPHY GUIDE CATHETERS
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 04547327079280 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.