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ACCU-FINE Pen Needles - Indonesia BPOM Medical Device Registration

ACCU-FINE Pen Needles is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20902124800. The device is manufactured by HTL-STREFA S.A from Poland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. 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
ACCU-FINE Pen Needles
Analysis ID: AKL 20902124800

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

HTL-STREFA S.A

Country of Origin

Poland

Authorized Representative

PT. ROCHE INDONESIA

AR Address

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

Registration Date

Nov 15, 2024

Expiry Date

Sep 24, 2025

Product Type

Therapeutic General and Individual Hospital Equipment

Hypodermic single lumen needle.

Non Electromedic Sterile

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