Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti
Active in EUDAMEDTürkiyefrom SRN EUDAMED SRN TR-MF-000014931
- Devices
- 30
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
What Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti makes
Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti manufactures occluder devices for treating congenital heart defects, including the PLD Occluder, PDA Occluder, and Muscular VSD Occluder.
The company's products are classified as Class III medical devices and are listed in the EUDAMED registry. Occlutech is based in Turkey.
Catalogue
Search and filter all 30 devicesCompany details
- EUDAMED SRN
- TR-MF-000014931
- EU VAT number
- 6330489704
- EUDAMED status
- Active
- EUDAMED registered name
- Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti
- EUDAMED abbreviated name
- Occlutech
- Registered address
- No:6, Yeşilköy SB Mah. E Blok Sok., 34149, İstanbul, Türkiye
- Website
- www.occlutech.com
- linkedin.com/company/occlutech
- [email protected]
- Phone
- +90 212 465 04 97
- PRRC contact
- Irem Bingul
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 19 Apr 2027
DEKRA Certification GmbH 0124 2 certificates
- 51322-61-A0-00 Active
Technical documentation EU MDR
- Issued
- 19 Mar 2024
- Expires
- 18 Mar 2029
- 51322-60-00-00 Expiring
Quality management system EU MDR
- Issued
- 19 Mar 2024
- Expires
- 19 Apr 2027
From the company website
Occlutech was founded in Germany in 2003, and has since developed into one of the world´s leading suppliers in the area of structural heart disease with products and projects for; congenital defects, stroke prevention, and heart failure.
Frequently asked questions
How many devices does Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti have in the registry?
The registry currently lists 30 devices for Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti. Devices recorded under merged duplicate company entries are counted once.
Which registries list Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti's devices?
Among its 30 most recently registered devices, Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti has devices listed in EUDAMED (30 devices).
What risk classes do Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti's devices fall under?
Among its 30 most recently registered devices, the classes recorded for Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti's devices are Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti?
EUDAMED lists 2 certificates for Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti (technical documentation; quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 19 Mar 2024.
What are the newest devices from Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti in the registry?
The most recently registered devices listed for Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti include Occlutech Pistol Pusher, Occlutech PLD Occluder, Occlutech PDA Occluder and Occlutech Muscular VSD Occluder.