Manufacturer profile
Roche Diagnostics GmbH
4065
Total Devices
18
Risk Classes
2017
Earliest Expiry
Recent products (latest 10)
Most recently added devices in the database
| Product Name | Risk Class | Detail |
|---|---|---|
| REFLOTRON GPT (ALT) | General IVD(Others) | View |
| REFLOTRON* UREA | General IVD(Others) | View |
| REFLOTRON* GLUGOSE | General IVD(Others) | View |
| REFLOTRON* TRIGLYCERIDES | General IVD(Others) | View |
| REFLOTRON GOT (AST) | General IVD(Others) | View |
| REFLOTRON URIC ACID | General IVD(Others) | View |
| CDC10 | General IVD(Others) | View |
| REFLOTRON BILIRUBIN | General IVD(Others) | View |
| REFLOTRON* CHOLESTROL | General IVD(Others) | View |
| REFLOTRON AMYLASE | General 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