EU Manufacturer
๐ฆ๐บ Australia
Active
Ellex Medical Pty Ltd
SRN: AU-MF-000004802
ยท
Second Avenue 3-4, 5095 Mawson Lakes, Australia
Basic UDI-DIs
17
Total Devices
29
On Market
29
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Second Avenue 3-4, 5095 Mawson Lakes, Australia
- [email protected]
- Phone
- +61 8 7074 8105
- Website
- https://www.ellex.com/
Regulatory Overview
Regulation
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Eu Mdd
15
Eu Mdr
2
Classification
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Eu Md Class 2b
17
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | MRA Q00068 | THERAPEUTIC GOODS ADMINISTRATION | May 20, 2016 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 2RT | EU MDD | Eu Md Class 2b | On Market | 1 |
| Integre Pro | EU MDR | Eu Md Class 2b | On Market | 0 |
| Integre Pro Green | EU MDD | Eu Md Class 2b | On Market | 1 |
| Integre Pro Red-Yellow | EU MDD | Eu Md Class 2b | On Market | 1 |
| Integre Pro Red-Yellow | EU MDR | Eu Md Class 2b | On Market | 0 |
| Integre Pro Scan Green | EU MDD | Eu Md Class 2b | On Market | 1 |
| Integre Pro Scan Green | EU MDR | Eu Md Class 2b | On Market | 0 |
| Integre Pro Scan Red-Yellow | EU MDR | Eu Md Class 2b | On Market | 0 |
| Integre Pro Scan Red-Yellow | EU MDD | Eu Md Class 2b | On Market | 1 |
| Integre Pro Scan Yellow | EU MDR | Eu Md Class 2b | On Market | 0 |
| Integre Pro Scan Yellow | EU MDD | Eu Md Class 2b | On Market | 1 |
| Integre Pro Yellow | EU MDD | Eu Md Class 2b | On Market | 1 |
| Integre Pro Yellow | EU MDR | Eu Md Class 2b | On Market | 0 |
| Solo | EU MDR | Eu Md Class 2b | On Market | 0 |
| Solo | EU MDD | Eu Md Class 2b | On Market | 1 |
| Tango | EU MDR | Eu Md Class 2b | On Market | 0 |
| Tango | EU MDD | Eu Md Class 2b | On Market | 1 |
| Tango Neo | EU MDD | Eu Md Class 2b | On Market | 1 |
| Tango Neo | EU MDR | Eu Md Class 2b | On Market | 0 |
| Tango Reflex | EU MDR | Eu Md Class 2b | On Market | 0 |
| Tango Reflex | EU MDD | Eu Md Class 2b | On Market | 1 |
| Tango Reflex Neo | EU MDR | Eu Md Class 2b | On Market | 0 |
| Tango Reflex Neo | EU MDD | Eu Md Class 2b | On Market | 1 |
| Ultra Q | EU MDD | Eu Md Class 2b | On Market | 1 |
| Ultra Q Reflex | EU MDD | Eu Md Class 2b | On Market | 1 |
| UltraQ | EU MDR | Eu Md Class 2b | On Market | 0 |
| UltraQ Reflex | EU MDR | Eu Md Class 2b | On Market | 0 |
| UltraQ Reflex Neo | EU MDR | Eu Md Class 2b | On Market | 0 |
| UltraQ Reflex Neo | EU MDD | Eu Md Class 2b | On Market | 1 |