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Elecsys Prolactin II - Indonesia BPOM Medical Device Registration

Elecsys Prolactin II is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324151. The device is manufactured by ROCHE DIAGNOSTICS (SUZHOU) LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ROCHE 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 : B
Elecsys Prolactin II
Analysis ID: AKL 20101324151

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

ROCHE INDONESIA

AR Address

Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi

Registration Date

Oct 25, 2023

Expiry Date

Jun 22, 2028

Product Type

Clinical Chemistry Test System

Prolactin (lactogen) test system (kit & cair)

Invitro Diagnostics

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