İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi
Active in EUDAMEDTürkiyefrom SRN EUDAMED SRN TR-MF-000024864
- Devices
- 9
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi makes
The company manufactures extracorporeal shock wave lithotripters (ESWL) for kidney stone fragmentation and intracorporeal pneumatic lithotripter systems for internal stone crushing. It also produces extracorporeal shock wave therapy (ESWT) devices, including combined ultrasonic-pneumatic systems for medical applications, as well as standalone ESWT systems for physiotherapy.
These devices are classified as Class I and Class IIb under EU regulations and are listed in the EUDAMED database and the FDA’s UDI system. The company is based in Turkey.
Catalogue
Modus Combined ESWT Ref IMEC-870
Regimes: CE MDR Registry: EUDAMEDModus ED - Modus Focused ESWT Ref IMED-850
Regimes: CE MDR Registry: EUDAMEDModus Internal Type - Modus Radial ESWT Ref IMET-800-1
Regimes: CE MDR Registry: EUDAMED- Regimes: CE MDD Registry: EUDAMED
Extracorporeal Shockwave Therapy (ESWT) Ref IMED-850
Regimes: CE MDD Registry: EUDAMEDGUDIDExtracorporeal Shock Wave Lithotripter (ESWL) Ref IMEM-900
Regimes: CE MDD Registry: EUDAMEDExtracorporeal Shockwave Therapy (ESWT) Ref IMET-800
Regimes: CE MDD Registry: EUDAMEDExtracorporeal Shock Wave Lithotripter (ESWL) Ref IMES-900
Regimes: CE MDD Registry: EUDAMEDIntracorporeal Pneumatic Lithotripter System Ref IMPL-700
Regimes: CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- TR-MF-000024864
- EU VAT number
- 4760661355
- EUDAMED status
- Active
- EUDAMED registered name
- İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi
- EUDAMED abbreviated name
- İnceler Medikal
- Registered address
- İvedik Organize Sanayi Bölgesi Mahallesi 1472.Cadde No:120, Yenimahalle, 06378, Ankara, Türkiye
- Website
- www.incelermedikal.com
- linkedin.com/company/3862336
- facebook.com/incelermed
- [email protected]
- Phone
- +905438096980
- PRRC contact
- Mehmet İnce
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 28 Apr 2031
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2541000-1 Active
Quality management system EU MDR
- Issued
- 29 Apr 2026
- Expires
- 28 Apr 2031
From the company website
Our ESWL devices are used in kidney stone fregmentation with lithotripsy devices and our ESWT devices used effectivley in physiotherapy. You can check our shockwave therapy devices from our website.
Frequently asked questions
How many devices does İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi have in the registry?
The registry currently lists 9 devices for İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi. Devices recorded under merged duplicate company entries are counted once.
Which registries list İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi's devices?
Among its 9 most recently registered devices, İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi has devices listed in EUDAMED (9 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi's devices fall under?
Among its 9 most recently registered devices, the classes recorded for İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi's devices are Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi?
EUDAMED lists 1 certificate for İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 29 Apr 2026.
What are the newest devices from İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi in the registry?
The most recently registered devices listed for İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi include Modus Combined ESWT, Modus ED - Modus Focused ESWT, Modus Internal Type - Modus Radial ESWT and Intracorporeal Combined Ultrasonic Pneumatic Kidney Stone Crushing Device.