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Urethral Dilator Sets

EUDAMED

Class IIa (EU MDR)

Ref IVX-TH-4241Ref IVX-TH-2161Ref IVX-TH-1261Ref IVX-TH-3201Ref IVX-TH-2081Ref IVX-TH-2121Ref IVX-TH-4221Ref IVX-TH-2241Ref IVX-TH-3261Ref IVX-TH-2261Ref IVX-TH-2181Ref IVX-TH-2201

by Innovex Medical Co., Ltd.

Identity

Device Name
Urethral Dilator Sets EUDAMED
Model / Reference
IVX-TH-4241 EUDAMED
IVX-TH-2161 EUDAMED
IVX-TH-1261 EUDAMED
IVX-TH-3201 EUDAMED
IVX-TH-2081 EUDAMED
IVX-TH-2121 EUDAMED
IVX-TH-4221 EUDAMED
IVX-TH-2241 EUDAMED
IVX-TH-3261 EUDAMED
IVX-TH-2261 EUDAMED
IVX-TH-2181 EUDAMED
IVX-TH-2201 EUDAMED

Identifiers

Primary DI / UDI-DI
06950203359204 EUDAMED
06950203359051 EUDAMED
06950203359532 EUDAMED
06950203359228 EUDAMED
06950203359013 EUDAMED
06950203359037 EUDAMED
06950203359198 EUDAMED
06950203359099 EUDAMED
06950203359259 EUDAMED
06950203359105 EUDAMED
06950203359068 EUDAMED
06950203359075 EUDAMED
Basic UDI-DI
69502033THC6 EUDAMED
EMDN Code
U03010201 URETHRAL 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

Urethral Dilator Sets 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

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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 (12)

  • EUDAMED d11c42fd-042d-4d83-8cf8-a93676ece1cd 61 fields · synced Oct 6, 2026
  • EUDAMED a2c649b8-f5ab-4575-b566-5258a4575895 61 fields · synced May 17, 2026
  • EUDAMED 200e3a06-745b-4954-8721-354a2acc4516 61 fields · synced May 17, 2026
  • EUDAMED a1e90f03-51f2-437e-887b-6fcd4b5108a3 61 fields · synced May 17, 2026
  • EUDAMED 7be18d83-fa0e-4205-8ec5-58b85d69a3a5 61 fields · synced May 18, 2026
  • EUDAMED f1f5e6ce-25a7-4c52-83d9-ff3223cbc2fb 61 fields · synced May 18, 2026
  • EUDAMED e599def2-6e1b-4735-8f35-3c05f16e335e 61 fields · synced May 18, 2026
  • EUDAMED 9778c50e-36b8-4adb-ae1a-d065e48f231f 61 fields · synced May 18, 2026
  • EUDAMED 66b4aeb3-6216-4501-b3eb-8bbfb660a507 61 fields · synced May 18, 2026
  • EUDAMED 8440855c-93b8-4a9e-9844-2e6fa923b4fe 61 fields · synced May 18, 2026
  • EUDAMED 91d6e107-209b-46ba-bb90-98de83075d8c 61 fields · synced May 18, 2026
  • EUDAMED 074be358-7283-42ca-9571-634fda6eb7a4 61 fields · synced May 19, 2026