CE-IVDR Rapid Diagnostic Tests -- HbA1c CRP Ferritin and Troponin I lateral flow assays

Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login

Corridor

India-Belgium

Mandate Type

sell

Principal Type

seller

Incoterm

CIF Antwerp

Price Range

EUR 3.50-8.50 per test depending on analyte

Payment Terms

LC at sight first 2 orders; net 45 days thereafter

Frequency

quarterly

Specification

All tests CE marked under EU IVDR 2017/746; Class C for HbA1c and CRP; Class D for Troponin I Notified Body mandatory; EUDAMED device registration; UDI per IUDID; HbA1c: NGSP-IFCC certified CV below 3%; Troponin I: 99th percentile detection hs-Troponin; shelf life 24 months at 2-30 degrees C; IFU in Dutch and French

Notes

Bengaluru diagnostics: ISO 13485; USFDA 510k for HbA1c and CRP. CE IVDR Class C certification target Q2 2026. Early supply possible under transitional provisions. Belgian hospital procurement via SPF Sante Publique approved vendor list.

← all mandates