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TRUCLEAR Elite Hysteroscopes - Indonesia BPOM Medical Device Registration

TRUCLEAR Elite Hysteroscopes is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21106910144. The device is manufactured by HENKE-SASS WOLF, GMBH. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MEDTRONIC 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
TRUCLEAR Elite Hysteroscopes
Analysis ID: AKL 21106910144

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

PT. MEDTRONIC INDONESIA

AR Address

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda

Registration Date

May 12, 2022

Expiry Date

Feb 16, 2027

Product Type

Diagnostic Obstetric and Gynaecological Equipment

Hysteroscope and accessories.

Non Electromedic Non Sterile

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