EU Manufacturer
🇸🇰 Slovakia
Active
TatraMed Software s.r.o.
SRN: SK-MF-000017681
·
Líčšie údolie 9, 841 04 Bratislava, Slovakia
Basic UDI-DIs
4
Total Devices
6
On Market
6
Off Market
0
Certificates
3
Valid
1
Expiring < 6mo
0
Countries
5
Watch TatraMed Software s.r.o. for changes
We'll email you when it registers new devices, or a certificate is issued or withdrawn.
Basic Information
- Address
- Líčšie údolie 9, 841 04 Bratislava, Slovakia
- [email protected]
- Phone
- +421 2 6020 2301
- Website
- www.tatramed.sk
Regulatory Overview
Regulation
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Eu Mdd
2
Eu Mdr
2
Classification
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Eu Md Class 1
2
Eu Md Class 2a
1
Eu Md Class 2b
1
Device Types
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Certificate Health
Total
3
Valid
1
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex VI | 2019-MDD/QS-032 | 3EC International a.s. | Apr 24, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-006 | 3EC International a.s. | Apr 26, 2024 | |||
| MDR QMS | 2024-MDR/QS-010 | 3EC International a.s. | MDR | Mar 2024 | Mar 06, 2029 | Issued |
Market Presence
Devices from this manufacturer are available in 5 countries across Europe.
🇨🇿 Czechia
🇩🇪 Germany
🇭🇺 Hungary
🇵🇱 Poland
🇸🇰 Slovakia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| RTmedes 1.6 | EU MDR | Eu Md Class 1 | On Market | 0 |
| TomoCon GO - versions 1.0, 2.0, 2.1, 2.2, 2.3, 2.4 | EU MDD | Eu Md Class 1 | On Market | 1 |
| TomoCon GO 3.0 | EU MDR | Eu Md Class 2a | On Market | 0 |
| TomoCon GO 4.0 | EU MDR | Eu Md Class 2a | On Market | 0 |
| TomoCon GO 5.0 | EU MDR | Eu Md Class 2a | On Market | 0 |
| TomoCon PACS | EU MDD | Eu Md Class 2b | On Market | 1 |