TOMTEC-ARENA - Indonesia BPOM Medical Device Registration
TOMTEC-ARENA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501122187. The device is manufactured by TOMTEC IMAGING SYSTEMS GMBH. from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. PHILIPS INDONESIA COMMERCIAL.
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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
TOMTEC IMAGING SYSTEMS GMBH.Country of Origin
Germany
Authorized Representative
PT. PHILIPS INDONESIA COMMERCIALAR Address
Gedung Cibis Nine Lantai 10, Jl. TB Simatupang No. 2
Registration Date
Mar 08, 2024
Expiry Date
Jan 20, 2026
Product Type
Diagnostic Radiology Equipment
Medical image management and processing system.
Non Radiation Electromedics
PHILIPS AneurysmFlow
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
PHILIPS PageWriter TC10 Cardiograph
PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
PRO-TECH Pro-Flow and Pro-Flow Plus Nasal Cannulas
PRO-TECH SERVICES, INC.
PHILIPS WISP Pediatric Nasal Mask
RESPIRONICS MEDICAL PRODUCTS (SHENZHEN) CO. LTD
PHILIPS PageWriter TC30 Cardiograph
PHILIPS MEDICAL SYSTEMS
PHILIPS Respironics Sleepware G3
RESPIRONICS INC.
DREAMSTATION BiPAP Pro
RESPIRONICS INC.
DREAMWEAR Silicone Pillows Mask
RESPIRONICS MEDICAL PRODUCTS (SHENZHEN) CO., LTD
PHILIPS RESPIRONICS DreamStation Humidifier
RESPIRONICS INC.
BV ENDURA
PHILIPS INDIA LIMITED.

