IDK Calprotectin ELISA - Indonesia BPOM Medical Device Registration

IDK Calprotectin ELISA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305612877. The device is manufactured by IMMUNDIAGNOSTIK AG. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is INTI MAKMUR MEDITAMA.

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Risk Class Kelas Resiko : B

IDK Calprotectin ELISA

Analysis ID: AKL 20305612877

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

IMMUNDIAGNOSTIK AG.

Country of Origin

Germany

Authorized Representative

INTI MAKMUR MEDITAMA

AR Address

JL. SULTAN ISKANDAR MUDA, GANDARIA 8 OFFICE TOWER LANTAI 16 UNIT F, KEBAYORAN LAMA JAKARTA SELATAN

Registration Date

Mar 13, 2024

Expiry Date

Sep 01, 2028

Product Type

Immunological Test System

Fecal calprotectin immunological test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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