MKCELLS Hemodialysis Machine - Indonesia BPOM Medical Device Registration

MKCELLS Hemodialysis Machine is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805220348. The device is manufactured by SWS HEMODIALYSIS CARE, CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. INTERSKALA SEHAT SEJAHTERA.

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BPOM Registered

Risk Class Kelas Resiko : C

MKCELLS Hemodialysis Machine

Analysis ID: AKL 20805220348

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

SWS HEMODIALYSIS CARE, CO., LTD.

Country of Origin

China

Authorized Representative

PT. INTERSKALA SEHAT SEJAHTERA

AR Address

INTERSKALA SEHAT SEJAHTERA

Registration Date

Sep 27, 2022

Expiry Date

Jul 19, 2025

Product Type

Therapeutic Gastroenterology-Urology Equipment

Hemodialysis system and accessories.

Non Radiation Electromedics

DJ Fang

MedTech Regulatory Expert

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MKCELLS Hemodialysis Machine

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