ATELLICA NEPH 630 System and Accessories - Indonesia BPOM Medical Device Registration
ATELLICA NEPH 630 System and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102022674. The device is manufactured by BIT ANALYTICAL INSTRUMENTS GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS INDONESIA.
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
BIT ANALYTICAL INSTRUMENTS GMBHCountry of Origin
Germany
Authorized Representative
PT. SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88
Registration Date
Jan 08, 2025
Expiry Date
Oct 19, 2026
Product Type
Clinical Laboratory Equipment
Nephelometer for clinical use.
Invitro Diagnostics
ADVIA Centaur Calibrator D
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
DIMENSION Revised C-Reactive Protein Calibrator (RCRP CAL)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE 2000 Systems Allergen Specific IgE Universal Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
IMMULITE 2000 3gAllergy Specific IgE Positive Control for D1 &D2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
ADVIA Centaur Anti-HBs2 Quality Control (aHBs2 QC)
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
DIMENSION Bilirubin Calibrator (TBI/DBI CAL)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
ADVIA Centaur CA 15-3
SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)
ADVIA Centaur Insulin (IRI)
MINARIS MEDICAL CO., LTD.
CLINITEK Status+ Analyzer and Accessories
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
DIMENSION Tacrolimus Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS INC.