ALTERNA Urostomy Bag [Upgrade 2pc uro] - Indonesia BPOM Medical Device Registration
ALTERNA Urostomy Bag [Upgrade 2pc uro] is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10805420263. The device is manufactured by COLOPLAST HUNGARY LTD from Hungary, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. DCH AURIGA INDONESIA.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
COLOPLAST HUNGARY LTDCountry of Origin
Hungary
Authorized Representative
PT. DCH AURIGA INDONESIAAR Address
DCH AURIGA INDONESIA
Registration Date
May 20, 2024
Expiry Date
Sep 30, 2027
Product Type
Therapeutic Gastroenterology-Urology Equipment
Ostomy pouch and accessories.
Non Electromedic Non Sterile
ALTERNA Urostomy Bag [Alterna Upgrade 1pc uro]
ALTERNA Ostomy Bag [Alterna Upgrade 1pc open]
ALTERNA Ostomy Bag [Upgrade 1 pc closed]
ALTERNA Ostomy Bag [Alterna Upgrade 2pc open]
ALTERNA Ostomy Bag [Upgrade 1 pc closed]
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