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INION OTPS FreedomPlate - Indonesia BPOM Medical Device Registration

INION OTPS FreedomPlate is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302818990. The device is manufactured by INION LTD from Finland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. PRO-HEALTH INTERNATIONAL.

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BPOM Registered
Risk Class Kelas Resiko : C
INION OTPS FreedomPlate
Analysis ID: AKL 21302818990

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

INION LTD

Country of Origin

Finland

Authorized Representative

PT. PRO-HEALTH INTERNATIONAL

AR Address

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

Registration Date

Jan 20, 2022

Expiry Date

Sep 30, 2026

Product Type

Prosthetic Orthopedic Equipment

Single/multiple component metallic bone fixation appliances and accessories.

Non Electromedic Sterile

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