AMARA Gel Mask - Indonesia BPOM Medical Device Registration
AMARA Gel Mask is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10403913450. The device is manufactured by SCIENTIFIC MOLDING CORPORATION, LTD. from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PHILIPS INDONESIA COMMERCIAL.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 1
Manufacturer
SCIENTIFIC MOLDING CORPORATION, LTD.Country of Origin
United States
Authorized Representative
PHILIPS INDONESIA COMMERCIALAR Address
Gedung Cibis Nine Lantai 10 Jl. TB Simatupang No. 2 RT.001 RW. 005 Kel. Cilandak Timur Kec. Pasar Minggu Jakarta Selatan
Registration Date
May 27, 2019
Expiry Date
Apr 10, 2024
Product Type
Therapeutic Anesthesia Equipment
Oxygen mask.
Non Electromedic Non Sterile
TRILOGY EV300
RESPIRONICS INC.
PHILIPS CT 5300
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
PHILIPS CT 5300
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
PHILIPS IntelliVue Active Display AD85
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
PHILIPS IntelliSite Pathology Solution
Philips Medical Systems Nederland B.V.
PHILIPS IntelliVue XDS Software
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH.
PHILIPS IntelliVue Guardian Software
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH.
PHILIPS CT 5300
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
PHILIPS CT 5300
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
EPIQ 5 Diagnostic Ultrasound System
PHILIPS ULTRASOUND, LLC.

