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REGAL Silicone Glove, Sleeve and Maxillofacial - Indonesia BPOM Medical Device Registration

REGAL Silicone Glove, Sleeve and Maxillofacial is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11402023311. The device is manufactured by REGAL PROSTHESIS LTD. from Hong Kong (China), and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ORTHOCARE INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : A
REGAL Silicone Glove, Sleeve and Maxillofacial
Analysis ID: AKL 11402023311

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

Hong Kong (China)

Authorized Representative

PT. ORTHOCARE INDONESIA

AR 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

May 29, 2023

Expiry Date

May 12, 2027

Product Type

Prosthetic Physical Health Equipment

Prosthetic and orthotic accessory.

Non Electromedic Non Sterile

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