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Ureteral Access Sheaths

EUDAMED

Class IIa (EU MDR)

Ref IVX-NS-1250Ref IVX-NS-0940Ref IVX-NS-1045Ref IVX-NS-1050Ref IVX-NS-1245DRef IVX-NS-1140DRef IVX-NS-1240DRef IVX-NS-1050DRef IVX-NS-1150Ref IVX-UA-1035Model IVX-UA-1035; IVX-UA-1045; IVX-UA-1135; IVX-UA-1145; IVX-UA-1235; IVX-UA-1245Ref IVX-NS-1045DRef IVX-UA-1045Ref IVX-NS-1240Ref IVX-NS-1040Ref IVX-NS-1235

by Innovex Medical Co., Ltd.

Identity

Device Name
Ureteral Access Sheaths EUDAMED
Model / Reference
IVX-NS-1250 EUDAMED
IVX-NS-0940 EUDAMED
IVX-NS-1045 EUDAMED
IVX-NS-1050 EUDAMED
IVX-NS-1245D EUDAMED
IVX-NS-1140D EUDAMED
IVX-NS-1240D EUDAMED
IVX-NS-1050D EUDAMED
IVX-NS-1150 EUDAMED
IVX-UA-1035; IVX-UA-1045; IVX-UA-1135; IVX-UA-1145; IVX-UA-1235; IVX-UA-1245 EUDAMED
IVX-UA-1035 EUDAMED
IVX-NS-1045D EUDAMED
IVX-UA-1045 EUDAMED
IVX-NS-1240 EUDAMED
IVX-NS-1040 EUDAMED
IVX-NS-1235 EUDAMED

Identifiers

Primary DI / UDI-DI
06950203341445 EUDAMED
06950203341629 EUDAMED
06950203341070 EUDAMED
06950203341438 EUDAMED
06950203341568 EUDAMED
06950203341513 EUDAMED
06950203341551 EUDAMED
06950203341490 EUDAMED
06950203341322 EUDAMED
06950203305188 EUDAMED
06950203341483 EUDAMED
06950203305195 EUDAMED
06950203341148 EUDAMED
06950203341063 EUDAMED
06950203341131 EUDAMED
Basic UDI-DI
69502033NSCA EUDAMED
69502033NSDYF EUDAMED
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

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Manufacturer

EUDAMED SRN
CN-MF-000015981
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (21)

  • EUDAMED 6dae4276-10f9-48e1-8638-b192a59f059a 61 fields · synced Oct 6, 2026
  • EUDAMED e3c1d4ba-45bb-45f6-8a92-2379fca55c0b 61 fields · synced May 17, 2026
  • EUDAMED c070d013-533a-450c-a52b-9d55dfae1426 61 fields · synced May 17, 2026
  • EUDAMED ba698be6-fa4b-4c16-a246-dd8550738205 61 fields · synced May 17, 2026
  • EUDAMED 838e044d-a3a4-42b2-922c-a67d325f8f49 61 fields · synced May 18, 2026
  • EUDAMED bfe19d1d-bf13-4735-8f96-98095af9acd2 61 fields · synced May 18, 2026
  • EUDAMED b2b9feac-bccc-4521-9375-03ebe3cb5a05 61 fields · synced May 18, 2026
  • EUDAMED e1afca1e-05ba-4682-b362-bd80c5fd4bea 61 fields · synced May 18, 2026
  • EUDAMED 20d5f2fd-7555-4e4a-9c0d-0427a9c2ac88 61 fields · synced May 18, 2026
  • EUDAMED 68170eb5-d344-4208-a4c8-5054de5d992f 61 fields · synced May 18, 2026
  • EUDAMED 41cea571-2d5d-4b10-9771-c3ba1af6815a 61 fields · synced May 18, 2026
  • EUDAMED 8ea436cf-92e5-4ab5-92ae-d4e1afc1a8f1 61 fields · synced May 19, 2026
  • EUDAMED 8bd5d931-fe7b-4e94-8dcc-5964d0d4043a 61 fields · synced May 19, 2026
  • EUDAMED aad37e6f-0d1b-467c-a695-9917943d9484 61 fields · synced May 19, 2026
  • EUDAMED 65fbca48-32a9-4156-85c3-adf9865e3809 61 fields · synced Jun 20, 2026
  • EUDAMED a0c06563-8408-4f54-bd5e-064dd0934f96 61 fields · synced Jul 9, 2026
  • EUDAMED bc71c3d0-5bf5-4fb5-8880-ecd76e06ce33 61 fields · synced Jul 11, 2026
  • EUDAMED c806320c-ab8e-4366-ac89-1bbd1f91a681 61 fields · synced Jul 17, 2026
  • EUDAMED da75e397-574b-4663-bba5-7ac4134e5067 61 fields · synced Jul 23, 2026
  • EUDAMED 3ede5fe5-40f3-426e-8c0f-86e7def7121e 61 fields · synced Jul 23, 2026
  • EUDAMED dc67136f-5cd5-4a44-bb74-64a4e5b9e4da 61 fields · synced Aug 2, 2026