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Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

HiPoint 88 reperfusion catheter with Tenzing 8

UDI-DI 00853799007305Basic UDI-DI 0853799007NRSEC

Class III · MDR · Route 92 Medical, Inc.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

1000236584

EU quality management system · unknown

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2025-05-16 · Expiry 2027-05-18

Scope not stated in certificate data.

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

1000209962

EU technical documentation assessment · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2025-03-10 · Expiry 2029-10-07

Scope not stated in certificate data.

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

Manufacturer

Route 92 Medical, Inc.

SRN US-MF-000007441

US · San Mateo

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hipoint-88-reperfusion-catheter-with-tenzing-8-7305 · UDI page: /udi/00853799007305

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