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Ureteral Dilator Sets
EUDAMEDClass IIa (EU MDR)
Ref IVX-TE-2081Ref IVX-TE-2091Ref IVX-TE-2161Ref IVX-TE-2141
Identity
- Device Name
- Ureteral Dilator Sets EUDAMED
- Model / Reference
- IVX-TE-2081 EUDAMEDIVX-TE-2091 EUDAMEDIVX-TE-2161 EUDAMEDIVX-TE-2141 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950203360026 EUDAMED06950203360033 EUDAMED06950203360088 EUDAMED06950203360071 EUDAMED
- Basic UDI-DI
- 69502033TEBY EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS 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
Category: Ureteral introduction sheath
Ureteral Dilator Sets by Innovex Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral introduction sheath.
- Manawa Access Sheath — ENVASTE LTD · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Disposable Ureteral Guide Sheath — Dongguan ZSR Biomedical Technology Company Limited · Class IIa
- Disposable access sheath — Hangzhou Hawk Medical Technology Co., Ltd · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd · Class II
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 | 69502033TEBY | 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 (4)
- EUDAMED b9230706-e9f5-4d82-b568-c8aa716d9873 61 fields · synced Jul 28, 2026
- EUDAMED b1f2bfc9-c469-4121-a87c-1803163e16d3 61 fields · synced May 17, 2026
- EUDAMED 35c8813a-fc8b-4d78-9a9e-2d0a0ebd7ec4 61 fields · synced May 18, 2026
- EUDAMED 1fde83b9-64ba-42c4-843d-1033351b51dd 61 fields · synced May 19, 2026