EU Manufacturer
🇷🇺 Russian Federation
Active
Research and Production Company «Monitor» Limited
SRN: RU-MF-000001877
·
Krasnokursantskaya 104a, 344068 Rostov-on-Don, Russian Federation
Basic UDI-DIs
9
Total Devices
9
On Market
9
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
31
Basic Information
- Address
- Krasnokursantskaya 104a, 344068 Rostov-on-Don, Russian Federation
- [email protected]
- Phone
- +7 863 243 63 77
- Website
- https://www.monitor-ltd.ru/en/
Regulatory Overview
Regulation
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Eu Mdd
9
Classification
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Eu Md Class 2a
8
Eu Md Class 2b
1
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Expired / Withdrawn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) | CE 543428 | BSI Group The Netherlands B.V. | Nov 26, 2023 |
Market Presence
Devices from this manufacturer are available in 31 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ECG Holter recorder EHR-01 | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG MACHINE EC12T 01 RD/141 | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG MACHINE EC12T 01 RD/260 | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG MACHINE EC3T 01 RD/1 | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG MACHINE EC3T 01 RD/2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG portable recorder EPR-01 | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG wireless recorder EWR-01 | EU MDD | Eu Md Class 2a | On Market | 1 |
| PATIENT MONITOR MITAR 01 RD | EU MDD | Eu Md Class 2b | On Market | 1 |
| Spirometer SMP 21/01 RD | EU MDD | Eu Md Class 2a | On Market | 1 |