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OSTEOMED Speaks-Fit - Indonesia BPOM Medical Device Registration

OSTEOMED Speaks-Fit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302110656. The device is manufactured by OSTEOMED from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PRO-HEALTH INTERNATIONAL.

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
OSTEOMED Speaks-Fit

OSTEOMED Talar-Fit

Analysis ID: AKL 21302110656

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

OSTEOMED

Country of Origin

United States

Authorized Representative

PRO-HEALTH INTERNATIONAL

AR Address

Komplek Perkantoran Duta Merlin Blok C 35-36 Jalan Gajah Mada 3-5

Registration Date

Dec 08, 2022

Expiry Date

Jul 05, 2027

Product Type

Prosthetic Orthopedic Equipment

Smooth or threaded metallic bone fixation fastener.

Non Electromedic Non Sterile

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