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UDI Compass
Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

Tenzing 7

UDI-DI 00853799007251Basic UDI-DI 08537990076001VF

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

170780332

EU technical documentation assessment · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2022-05-19 · Expiry 2027-05-18

Scope not stated in certificate data.

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

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.

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

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/tenzing-7-7251 · UDI page: /udi/00853799007251

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