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SAM Splint - Indonesia BPOM Medical Device Registration

SAM Splint is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11402420406. The device is manufactured by SAM MEDICAL PRODUCTS from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. RANAYA FAZZA UTAMA.

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 : A
SAM Splint
Analysis ID: AKL 11402420406

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

United States

Authorized Representative

PT. RANAYA FAZZA UTAMA

AR Address

Ruko Grand Wisata, Festive Garden Blok/KAV AA16/53

Registration Date

Oct 14, 2024

Expiry Date

Jan 14, 2027

Product Type

Prosthetic Physical Health Equipment

External limb orthotic component.

Non Electromedic Non Sterile

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