Pure Global

NEWTOM X-PSP - Indonesia BPOM Medical Device Registration

NEWTOM X-PSP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501220257. The device is manufactured by CEFLA S.C from Italy, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. KIRANA JAYA LESTARI.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
NEWTOM X-PSP
Analysis ID: AKL 21501220257

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

CEFLA S.C

Country of Origin

Italy

Authorized Representative

PT. KIRANA JAYA LESTARI

AR Address

JL. TANAH ABANG II NO. 37

Registration Date

Jun 17, 2022

Expiry Date

Feb 28, 2027

Product Type

Diagnostic Radiology Equipment

Medical image digitizer.

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing