Manufacturer profile

Roche Diagnostics GmbH

Saudi Arabia flagSaudi Arabia·4065 devices
4065
Total Devices
18
Risk Classes
2017
Earliest Expiry
Recent products (latest 10)

Most recently added devices in the database

Product NameRisk ClassDetail
REFLOTRON GPT (ALT)General IVD(Others)View
REFLOTRON* UREAGeneral IVD(Others)View
REFLOTRON* GLUGOSEGeneral IVD(Others)View
REFLOTRON* TRIGLYCERIDESGeneral IVD(Others)View
REFLOTRON GOT (AST)General IVD(Others)View
REFLOTRON URIC ACIDGeneral IVD(Others)View
CDC10General IVD(Others)View
REFLOTRON BILIRUBINGeneral IVD(Others)View
REFLOTRON* CHOLESTROLGeneral IVD(Others)View
REFLOTRON AMYLASEGeneral IVD(Others)View
Risk class distribution

Breakdown by risk classification

General IVD(Others)
3527(86.8%)
Class I
105(2.6%)
Annex II List A
93(2.3%)
Annex II List B
67(1.6%)
1
42(1.0%)
B
39(1.0%)
2
34(0.8%)
N/A
32(0.8%)
3
29(0.7%)
C
26(0.6%)
A
23(0.6%)
Self Test
23(0.6%)
3.0
14(0.3%)
2.0
4(0.1%)
D
2(0.0%)
4.0
2(0.0%)
1.0
2(0.0%)
Class II
1(0.0%)
About this profile

Explore comprehensive manufacturer profile for Roche Diagnostics GmbH through Pure Global AI's free Saudi Arabia medical device database. This company manufactures 4065 medical devices registered with SFDA across 18 risk classes.

This page provides detailed insights including recent registrations, risk class distribution (1: 42, 2: 34, 3: 29, General IVD(Others): 3527, B: 39, ...), and complete regulatory information from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry.

Free Manufacturer ProfilePowered by Pure Global AI4065 Devices18 Risk Classes