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PORTEX Orator ™ Tracheostomy Speaking Valve - Indonesia BPOM Medical Device Registration

PORTEX Orator ™ Tracheostomy Speaking Valve is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20403220378. The device is manufactured by SMITHS HEALTHCARE MANUFACTURING SA DE C.V. from Mexico, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is IDS MEDICAL SYSTEMS INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
PORTEX Orator ™ Tracheostomy Speaking Valve
Analysis ID: AKL 20403220378

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Mexico

Authorized Representative

IDS MEDICAL SYSTEMS INDONESIA

AR Address

Gedung Wisma 76, Lantai 17 & 22, Jl. LetJend. S. Parman Kav.76, Kelurahan Slipi, Kecamatan Palmerah, 11410

Registration Date

Feb 01, 2025

Expiry Date

Nov 22, 2029

Product Type

Therapeutic Anesthesia Equipment

Tracheostomy tube and tube cuff.

Non Electromedic Sterile

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