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TOTALSHIELD ® II Surgical Helmet System (00992000100) - Indonesia BPOM Medical Device Registration

TOTALSHIELD ® II Surgical Helmet System (00992000100) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603026162. The device is manufactured by DORNOCH MEDICAL SYSTEMS INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. KALMED SEJAHTERA 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
TOTALSHIELD ® II Surgical Helmet System (00992000100)
Analysis ID: AKL 21603026162

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. KALMED SEJAHTERA INDONESIA

AR Address

Jl. TMII Pintu II No. 2, RT 006 RW 004,

Registration Date

Oct 16, 2020

Expiry Date

Nov 19, 2024

Product Type

Surgical Equipment

Surgical apparel.

Non Radiation Electromedics

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