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Ureteral Access Sheaths

EUDAMED

Class IIa (EU MDR)

Ref IVX-NS-1250D

by Innovex Medical Co., Ltd.

Identity

Device Name
Ureteral Access Sheaths EUDAMED
Model / Reference
IVX-NS-1250D EUDAMED

Identifiers

Primary DI / UDI-DI
06950203341575 EUDAMED
Basic UDI-DI
69502033NSDYF 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 (2)

  • EUDAMED af8e7850-1229-4c6e-a91e-d292229b6eca 61 fields · synced Oct 6, 2026
  • EUDAMED 022b0fbc-680f-4623-af77-9967af0f0e6e 61 fields · synced Oct 6, 2026