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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

hemochroma PLUS Control Set

UDI-DI 08806133050026Basic UDI-DI 880613306013CN

Class B · IVDR · Boditech Med Inc.

Identification
Model
hemochroma PLUS Control Set
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

V76 053112 0038

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-09-21 · Expiry 2031-09-20

Scope not stated in certificate data.

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

Manufacturer

Boditech Med Inc.

SRN KR-MF-000011028

KR · Chuncheon-si

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

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/hemochroma-plus-control-set-0026 · UDI page: /udi/08806133050026

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