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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Hyrespira 5-in-1 Rapid Test

UDI-DI 04251743800563Basic UDI-DI 4251743800016UW

Class C · IVDR · Heyer Medical AG

Identification
Model
Multiple Models
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

EU-TDA-FI-92091-800168-2026

EU technical documentation assessment · valid

Notified body: Kiwa Sertio Oy (3018)

Valid from 2026-07-14 · Expiry 2031-07-14

Scope not stated in certificate data.

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

EU-QMS-FI-88700-800168-2026

EU quality management system · valid

Notified body: Kiwa Sertio Oy (3018)

Valid from 2026-07-14 · Expiry 2031-07-14

Scope not stated in certificate data.

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

Manufacturer

Heyer Medical AG

SRN DE-MF-000014330

DE · Schwerin

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hyrespira-5-in-1-rapid-test-0563 · UDI page: /udi/04251743800563

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