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InRo- Semi-Compliant Coronary Balloon Catheter 3.5mmx20mm
EUDAMEDClass III (EU MDR)
Ref IR35/20Model InRo® Family
Identity
- Trade Name
- InRo® EUDAMED
- Device Name
- InRo- Semi-Compliant Coronary Balloon Catheter 3.5mmx20mm EUDAMEDInRo Coronary Balloon Catheter EUDAMED
- Model / Reference
- IR35/20 EUDAMEDInRo® Family EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630033312714 EUDAMED
- Basic UDI-DI
- B-07630033312714 EUDAMED076300333IF_CBLCATHL4 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Coronary angioplasty balloon catheter, cutting/scoring
InRo- Semi-Compliant Coronary Balloon Catheter 3.5mmx20mm by Rontis Corporation SA — Class III — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
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- Invader PTCA — Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. · Class III
- Wolverine Coronary Cutting Balloon — Boston Scientific · Class III
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07630033312714 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-07630033312714 | Class III | Active |
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Manufacturer
- Manufacturer
- Rontis Corporation SA
- EUDAMED SRN
- CH-MF-000031411
- Authorised Representative
- RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A. GR-AR-000023077
Sources (2)
- EUDAMED 4fb15dd4-5bc7-4536-91f7-3b52f1f56fef 61 fields · synced Jul 8, 2026
- EUDAMED 9bbfa9ee-ac71-4086-aadb-7887634004b0 61 fields · synced May 18, 2026