Artificial Urinary Sphincter Pre-Filled - Indonesia BPOM Medical Device Registration
Artificial Urinary Sphincter Pre-Filled is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30805123432. The device is manufactured by ZEPHYR SURGICAL IMPLANTS SARL from Switzerland, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is EDISON AMBASSADOR MEANS.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
ZEPHYR SURGICAL IMPLANTS SARLCountry of Origin
Switzerland
Authorized Representative
EDISON AMBASSADOR MEANSAR Address
Jl. Oasis Sememi Raya No. 1 RT 01 RW 04
Registration Date
Jun 16, 2021
Expiry Date
May 27, 2025
Product Type
Therapeutic Gastroenterology-Urology Equipment
Implanted mechanical/hydraulic urinary continence device.
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