EU Manufacturer
๐ต๐ฑ Poland
Active
OPTOPOL Technology Sp. z o.o.
SRN: PL-MF-000004770
ยท
ลปabia 42, 42-400 Zawiercie, Poland
Basic UDI-DIs
16
Total Devices
22
On Market
22
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
26
Basic Information
- Address
- ลปabia 42, 42-400 Zawiercie, Poland
- [email protected]
- Phone
- +48 32 67 091 73
- Website
- www.optopol.com.pl
Regulatory Overview
Regulation
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Eu Mdd
8
Eu Mdr
8
Classification
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Eu Md Class 2a
11
Eu Md Class 1
5
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Expired / Withdrawn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 | |||
|---|---|---|---|---|---|---|
| MDD Annex V | DD 60147392 0001 | TรV Rheinland LGA Products GmbH | May 26, 2024 | |||
| MDD Annex V | DD601473920001 | TรV Rheinland LGA Products GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 26 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
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| PTS 2000 | EU MDR | Eu Md Class 1 | On Market | 0 |
| PTS 920 | EU MDR | Eu Md Class 1 | On Market | 0 |
| PTS 920 BY | EU MDR | Eu Md Class 1 | On Market | 0 |
| PTS 925 W | EU MDR | Eu Md Class 1 | On Market | 0 |
| REVO 60 | EU MDD | Eu Md Class 2a | On Market | 1 |
| REVO 80 | EU MDD | Eu Md Class 2a | On Market | 1 |
| REVO FC | EU MDD | Eu Md Class 2a | On Market | 1 |
| REVO FC 130 | EU MDD | Eu Md Class 2a | On Market | 1 |
| REVO HR | EU MDD | Eu Md Class 2a | On Market | 1 |
| REVO nx | EU MDD | Eu Md Class 2a | On Market | 1 |
| REVO nx 130 | EU MDD | Eu Md Class 2a | On Market | 1 |
| SOCT | EU MDR | Eu Md Class 2a | On Market | 0 |
| SOCT | EU MDD | Eu Md Class 2a | On Market | 1 |
| Spectral Optical Coherence Tomographer REVO 60 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Spectral Optical Coherence Tomographer REVO 80 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Spectral Optical Coherence Tomographer REVO FC | EU MDR | Eu Md Class 2a | On Market | 0 |
| Spectral Optical Coherence Tomographer REVO FC 130 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Spectral Optical Coherence Tomographer REVO HR | EU MDR | Eu Md Class 2a | On Market | 0 |
| Spectral Optical Coherence Tomographer REVO nx | EU MDR | Eu Md Class 2a | On Market | 0 |
| Spectral Optical Coherence Tomographer REVO nx 130 | EU MDR | Eu Md Class 2a | On Market | 0 |
| UWF Adapter | EU MDR | Eu Md Class 1 | On Market | 0 |
| uSee | EU MDR | Eu Md Class 1 | On Market | 0 |