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STANDARD F D-dimer FIA - Indonesia BPOM Medical Device Registration

STANDARD F D-dimer FIA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207420111. The device is manufactured by SD BIOSENSOR HEALTHCARE PVT. LTD. from India, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is STANDARD BIOSENSOR INDONESIA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : C
STANDARD F D-dimer FIA
Analysis ID: AKL 20207420111

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

India

Authorized Representative

STANDARD BIOSENSOR INDONESIA

AR Address

L'AVENUE BUILDING UNIT C, LT. 21, JL. RAYA PASAR MINGGU KAV. 16

Registration Date

Jul 31, 2024

Expiry Date

Jan 18, 2029

Product Type

Haematology Package and Kit

Fibrinogen/fibrin degradation products assay.

Invitro Diagnostics

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