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Ureteral Dilation Balloon Catheters
EUDAMEDClass IIa (EU MDR)
Ref IVX-UB-MY05060Model IVX-UB-MY04040; IVX-UB-MY05060; IVX-UB-MY07060
Identity
- Device Name
- Ureteral Dilation Balloon Catheters EUDAMED
- Model / Reference
- IVX-UB-MY04040; IVX-UB-MY05060; IVX-UB-MY07060 EUDAMEDIVX-UB-MY05060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950203328279 EUDAMED
- Basic UDI-DI
- 69502033UBMYRM EUDAMED
- EMDN Code
- U030202 URETERAL DILATORS, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Ureteral Dilation Balloon Catheters by Innovex Medical Co., Ltd. — Class IIa — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69502033UBMYRM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Innovex Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000015981
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 3b7a3d9b-2309-485f-9356-848e91226b53 61 fields · synced Oct 6, 2026