EU Manufacturer
🇺🇦 Ukraine
Active
Limited Liability Company Research and Production Enterprise "DХ-SYSTEMS"
SRN: UA-MF-000016929
·
Tobolska 42, 61072 Kharkiv, Ukraine
Basic UDI-DIs
4
Total Devices
4
On Market
4
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Tobolska 42, 61072 Kharkiv, Ukraine
- [email protected]
- Phone
- +38 067 572 49 49
- Website
- dx-systems.com
Regulatory Overview
Regulation
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Eu Mdd
4
Classification
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Eu Md Class 2a
4
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 144868-19-04-02 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Mar 31, 2024 | |||
| MDD Annex II (excluding section 4) | 144884-19-05-14 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Apr 01, 2024 | |||
| MDD Annex II (excluding section 4) | 145003-20-09-28 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Apr 01, 2024 | |||
| MDD Annex II (excluding section 4) | 145004-20-09-28 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Apr 01, 2024 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇩🇪 Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| DX BRAINTEST PLUS | EU MDD | Eu Md Class 2a | On Market | 1 |
| DX M-TEST | EU MDD | Eu Md Class 2a | On Market | 1 |
| DX M-TEST ONE | EU MDD | Eu Md Class 2a | On Market | 1 |
| ELECTROENCEPHALOGRAPHS | EU MDD | Eu Md Class 2a | On Market | 1 |