Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

TRUEVISION Intravascular Ultrasound Imaging Catheter

UDI-DI 06971318440236Basic UDI-DI 697131844002C87

Class III · MDR · Insight Lifetech Co., Ltd.

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Identification

Model: 02-6F40-02; 02-6F60-02
EMDN: C0104010102
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 786854

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2025-12-16 · Expiry 2029-03-10

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Insight Lifetech Co., Ltd.

SRN CN-MF-000011205

CN · Shenzhen

manufacturer

Authorised representative: MedNet EC-REP C III GmbH (DE-AR-000011196)

Related UDI-DIs

TRUEVISION 06971318442148
TRUEVISION 06971318442155
TRUEVISION Intravascular Ultrasound Imaging Catheter 06971318440229

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/truevision-intravascular-ultrasound-imaging-catheter-0236 · UDI page: /udi/06971318440236

All devices from Insight Lifetech Co., Ltd.

Scan an inventory CSV