EU Manufacturer
๐จ๐ฟ Czechia
Active
IMMUNOTECH s.r.o.
SRN: CZ-MF-000001761
ยท
Radiova 1122/1, 10200 Prague 10, Czechia
Basic UDI-DIs
55
Total Devices
64
On Market
64
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
31
Basic Information
- Address
- Radiova 1122/1, 10200 Prague 10, Czechia
- [email protected]
- Phone
- +(420) 272 017 444
- Website
- beckmancoulter.com
Regulatory Overview
Regulation
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Eu Ivdr
55
Classification
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Eu Ivd Class B
47
Eu Ivd Class C
7
Eu Ivd Class A
1
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 31 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
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 | ||||
|---|---|---|---|---|
| ACTIVEยฎ Aldosterone RIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ACTIVEยฎ Androstanediol Glucuronide RIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ACTIVEยฎ Androstenedione RIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ACTIVEยฎ Dihydrotestosterone RIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ACTIVEยฎ Free Testosterone RIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ACTIVEยฎ IGFBP-3 IRMA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ACTIVEยฎ PTHrP IRMA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ACTIVEยฎ Renin IRMA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| AFP IRMA KIT | EU IVDR | Eu Ivd Class C | On Market | 0 |
| AFP screening IRMA KIT | EU IVDR | Eu Ivd Class C | On Market | 0 |
| AMH Gen II Calibrators and Controls | EU IVDR | Eu Ivd Class B | On Market | 0 |
| AMH Gen II ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| AMH Gen II ELISA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Albumin RIA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Angiotensin I RIA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Anti-TPO RIA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Anti-hTg IRMA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| DHEA RIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| EIA Histamine | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Estrone RIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Estrone Sulfate RIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FSH IRMA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FSH IRMA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FT4 Plus RIA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FT4 Plus RIA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FT4 RIA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FT4 RIA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Ferritin IRMA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Free Testosterone EIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| IRMA GH | EU IVDR | Eu Ivd Class B | On Market | 0 |
| IRMA IGF-I | EU IVDR | Eu Ivd Class B | On Market | 0 |
| IRMA PTH | EU IVDR | Eu Ivd Class B | On Market | 0 |
| IRMA PTH | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Inhibin A ELISA | EU IVDR | Eu Ivd Class C | On Market | 0 |
| LH IRMA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| LH IRMA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Ostase IRMA KIT | EU IVDR | Eu Ivd Class B | On Market | 0 |
| PSA free IRMA KIT | EU IVDR | Eu Ivd Class C | On Market | 0 |
| PSA total IRMA KIT | EU IVDR | Eu Ivd Class C | On Market | 0 |
| RIA 17ฮฑ-Hydroxyprogesterone | EU IVDR | Eu Ivd Class B | On Market | 0 |
| RIA Aldosterone | EU IVDR | Eu Ivd Class B | On Market | 0 |
| RIA DHEA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| RIA Estradiol | EU IVDR | Eu Ivd Class B | On Market | 0 |
| RIA FT3 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| RIA FT3 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| RIA Histamine | EU IVDR | Eu Ivd Class B | On Market | 0 |
| RIA Progesterone | EU IVDR | Eu Ivd Class B | On Market | 0 |
| RIA Testosterone | EU IVDR | Eu Ivd Class B | On Market | 0 |
| RIA Testosterone, direct | EU IVDR | Eu Ivd Class B | On Market | 0 |
| RIA Unconjugated Estriol | EU IVDR | Eu Ivd Class C | On Market | 0 |