SOFTGUARDS Hinged Knee Support (MPE 12003) - Indonesia BPOM Medical Device Registration
SOFTGUARDS Hinged Knee Support (MPE 12003) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11402127050. The device is manufactured by KAO CHEN ENTERPRISE CO. LTD. from Taiwan (China), and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ORTHOCARE INDONESIA.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
KAO CHEN ENTERPRISE CO. LTD.Country of Origin
Taiwan (China)
Authorized Representative
PT. ORTHOCARE INDONESIAAR Address
RUKO GALERI NIAGA MEDITERNIA 2 BLOK N 8 J , JL.PANTAI INDAH UTARA II RT/RW : 007/008 KEL KAPUK MUARA KEC. PENJARINGAN KOTA ADM JAKARTA UTARA
Registration Date
Jul 03, 2024
Expiry Date
Aug 01, 2029
Product Type
Prosthetic Physical Health Equipment
Limb orthosis.
Non Electromedic Non Sterile
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