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PROMEBA Air Splints - Indonesia BPOM Medical Device Registration

PROMEBA Air Splints is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11602320175. The device is manufactured by PRODUCTOS METALICOS DEL BAGES, S.L., from Spain, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. PENTASADA SOLAR DYNAMICS.

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.

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BPOM Registered
Risk Class Kelas Resiko : A
PROMEBA Air Splints
Analysis ID: AKL 11602320175

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

Spain

Authorized Representative

PT. PENTASADA SOLAR DYNAMICS

AR Address

Jl. Menceng Raya No. 2 RT.003 RW.011 Kel. Tegal Alur Kec. Kalideres, Jakarta Barat 11820

Registration Date

Mar 21, 2023

Expiry Date

Sep 07, 2025

Product Type

Prosthetic Surgical Equipment

Inflatable extremity splint.

Non Electromedic Non Sterile

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