EU Manufacturer ๐Ÿ‡ฆ๐Ÿ‡บ Australia Active

Atomo Diagnostics Limited

SRN: AU-MF-000024146 ยท George Street Level 1, 3-5, 2040 Leichhardt, Australia
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
13

Basic Information

Address
George Street Level 1, 3-5, 2040 Leichhardt, Australia

Regulatory Overview

Regulation
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Eu Ivdd 2
Classification
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Eu Ivd Annex 2 List A 2
Device Types
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Certificate Health

Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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Type Number Expiry Date Status
IVDD Annex IV Section 4 716015 May 26, 2025
IVDD Annex IV (excluding sections 4, 6) 637070 May 26, 2025

Market Presence

Devices from this manufacturer are available in 13 countries across Europe.

๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

Device Portfolio

Name
Simplitude ByMe
Simplitude ByMe