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FIBER-SPLINT - Indonesia BPOM Medical Device Registration

FIBER-SPLINT is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10602913793. The device is manufactured by POLYDENTIA SA from Switzerland, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. PURE NOBLE SUN.

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
FIBER-SPLINT
Analysis ID: AKL 10602913793

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Manufacturer

POLYDENTIA SA

Country of Origin

Switzerland

Authorized Representative

PT. PURE NOBLE SUN

AR Address

Jl. Pecenongan No. 82 C Kebon Kelapa, Kec. Gambir Jakarta Pusat 10120

Registration Date

Jan 20, 2021

Expiry Date

Dec 31, 2023

Product Type

Prosthetic Dental Equipment

Retentive and splinting pin.

Non Electromedic Non Sterile

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