Identity
- Trade Name
- ihtEvolve 3.5(SC)/4(NC)x15mm EUDAMED
- Device Name
- PTCA Dilatation Catheter EUDAMED
- Model / Reference
- 0067353 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08428097930406 EUDAMED
- Basic UDI-DI
- B-08428097930406 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Coronary angioplasty balloon catheter, cutting/scoring
ihtEvolve 3.5(SC)/4(NC)x15mm by Iberhospitex, S.A. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08428097930406 | Class III | Active |
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Manufacturer
- Manufacturer
- Iberhospitex, S.A.
- EUDAMED SRN
- ES-MF-000000160
Sources (1)
- EUDAMED 65603223-eb18-4998-b81d-64e19b184c3c 61 fields · synced Aug 1, 2026