Skip to content
UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Mycobacterium Tuberculosis Nucleic Acid Assay Control

UDI-DI 06975327121315Basic UDI-DI 697532712CRM1010602AG

Class C · IVDR · Guangzhou Pluslife Biotech Co., Ltd

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

EU-TDA-FI-34440-800076-2026

EU technical documentation assessment · valid

Notified body: Kiwa Sertio Oy (3018)

Valid from 2026-09-18 · Expiry 2031-09-18

Scope not stated in certificate data.

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

Manufacturer

Guangzhou Pluslife Biotech Co., Ltd

SRN CN-MF-000025784

CN · Guangzhou, Guangdong,

manufacturer

Authorised representative: Medunion S.L. (ES-AR-000019366)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/mycobacterium-tuberculosis-nucleic-acid-assay-control-1315 · UDI page: /udi/06975327121315

Scan an inventory CSV