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NUWELLIS Dual Lumen Catheter and Insertion Kit - Indonesia BPOM Medical Device Registration

NUWELLIS Dual Lumen Catheter and Insertion Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805420034. The device is manufactured by NUWELLIS, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TRANSMEDIC INDONESIA.

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Risk Class Kelas Resiko : C
NUWELLIS Dual Lumen Catheter and Insertion Kit
Analysis ID: AKL 20805420034

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

NUWELLIS, INC.

Country of Origin

United States

Authorized Representative

PT. TRANSMEDIC INDONESIA

AR Address

PERKANTORAN MENARA ERA UNIT G-01, JL. SENEN RAYA NO. 135-137

Registration Date

Jan 16, 2024

Expiry Date

Nov 30, 2028

Product Type

Therapeutic Gastroenterology-Urology Equipment

Blood access device and accessories.

Non Electromedic Sterile

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