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LORNE Anti-A Monoclonal Blood Grouping Reagents - Indonesia BPOM Medical Device Registration

LORNE Anti-A Monoclonal Blood Grouping Reagents is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209910815. The device is manufactured by LORNE LABORATORIES LIMITED from United Kingdom, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. RAFA TOPAZ MAIN.

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
LORNE Anti-A Monoclonal Blood Grouping Reagents
Analysis ID: AKL 20209910815

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United Kingdom

Authorized Representative

PT. RAFA TOPAZ MAIN

AR Address

Taman Buaran Indah I Blok U No. 242 Jl. Radin Inten II, Klender, Jakarta Timur

Registration Date

Oct 23, 2024

Expiry Date

Sep 17, 2028

Product Type

Products used in the manufacture of blood preparations and preparations of origin and blood

Blood group substances of nonhuman origin for in vitro diagnostic use.

Invitro Diagnostics

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