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Ureteral Access Sheaths
EUDAMEDClass IIa (EU MDR)
Ref IVX-UA-1135Model IVX-UA-1035; IVX-UA-1045; IVX-UA-1135; IVX-UA-1145; IVX-UA-1235; IVX-UA-1245
Identity
- Device Name
- Ureteral Access Sheaths EUDAMED
- Model / Reference
- IVX-UA-1035; IVX-UA-1045; IVX-UA-1135; IVX-UA-1145; IVX-UA-1235; IVX-UA-1245 EUDAMEDIVX-UA-1135 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950203305287 EUDAMED
- Basic UDI-DI
- 69502033UABT EUDAMED
- EMDN Code
- U020199 URETERAL CATHETERS WITHOUT BALLOON - OTHER 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 Access Sheaths by Innovex Medical Co., Ltd. — Class IIa — 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 | 69502033UABT | 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 7650a07c-6a0d-4ddc-8cc7-f90d206d3137 61 fields · synced Jun 19, 2026