Iberhospitex, S.A.
Active in EUDAMEDSpainfrom SRN EUDAMED SRN ES-MF-000000160
- Devices
- 223
- Registrations
- EUDAMED
At a glance
EU certificates
5 of 5 in force.
Market reach
- European Union
- EUDAMED actor, 5 certificates
What Iberhospitex, S.A. makes
Iberhospitex, S.A. manufactures cutting/scoring coronary angioplasty balloon catheters, including the ihtEvolve series with varying sizes and configurations, as well as sterile protective films and tapes for medical use, such as the OPER FILM PROTECT CHG and OPER TAPE.
The company’s products are classified as Class I and Class III medical devices, with records listed in the EU’s eudamed registry and the FDA’s 510(k) database. The manufacturer is based in Spain.
Catalogue
Search and filter all 223 devicesShowing 1-50 of 223
Company details
- EUDAMED SRN
- ES-MF-000000160
- EU VAT number
- ESA08630063
- EUDAMED status
- Active
- EUDAMED registered name
- Iberhospitex, S.A.
- EUDAMED abbreviated name
- IHT
- Registered address
- 4, Av. Catalunya, 08185, Lliçà de Vall, Spain
- Website
- www.iht.es
- info@iht.es
- Phone
- +34938436034
- PRRC contact
- Montserrat Barbany
EUDAMED certificates
5 certificates5 valid, 0 expiredMDR 5next expiry 10 Oct 2027
CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS 0318 3 certificates
- 2024 PR 0030 Active
Quality assurance EU MDR
- Issued
- 20 Apr 2026
- Expires
- 1 Jul 2029
- 2025 CR 0045 Active
Quality management system EU MDR
- Issued
- 28 May 2026
- Expires
- 1 Jul 2029
- Reason
- Add device or group
- 2026 DR 0088 Active
Technical documentation EU MDR
- Issued
- 14 May 2026
- Expires
- 1 Jul 2029
SGS Belgium NV 1639 2 certificates
- ES25/00000120 Active
Technical documentation EU MDR
- Issued
- 7 Jul 2025
- Expires
- 5 Feb 2030
- ES22/00000630 Expiring
Quality management system EU MDR
- Issued
- 11 Jul 2025
- Expires
- 10 Oct 2027
- Reason
- Change approved
Frequently asked questions
How many devices does Iberhospitex, S.A. have in the registry?
The registry currently lists 223 devices for Iberhospitex, S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iberhospitex, S.A.'s devices?
Among its 50 most recently registered devices, Iberhospitex, S.A. has devices listed in EUDAMED (50 devices).
What risk classes do Iberhospitex, S.A.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Iberhospitex, S.A.'s devices are Class I, Class IIa and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Iberhospitex, S.A.?
EUDAMED lists 5 certificates for Iberhospitex, S.A. (technical documentation; quality assurance; quality management system) under MDR. 3 are recorded with the status issued. The most recent was issued on 28 May 2026.
What are the newest devices from Iberhospitex, S.A. in the registry?
The most recently registered devices listed for Iberhospitex, S.A. include ihtDEStiny®, DRENOFAST, BOLSAS DE PROTECCIÓN and Oper film protect 10 x 12 cm.