Eu Ivdr
Eu Ivd Class C
On The Market
๐จ๐ฟ Czechia
PSA total IRMA KIT
Devices (same UDI-DI)
1
Certificates
0
Countries
15
Notified Bodies
0
Basic Information
- Primary DI
- 15099590216207
- Basic UDI-DI Code
- 150995905IM19506A
- Reference
- IM1950
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- IMMUNOTECH s.r.o.
Additional Description
PSA total IRMA KIT is an in vitro diagnostic manual medical device intended to be used by healthcare professionals for the quantitative measurement of total prostate specific antigen (PSA) in human serum. Measurement of total prostate specific antigen is intended to be used in diagnosis, prognosis and monitoring of prostate cancer. In combination with free PSA, it is used for differential diagnosis between prostate cancer and benign prostate hyperplasia in men.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030113 | TOTAL PROSTATIC SPECIFIC ANTIGEN |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ต๐ฑ Poland
๐ธ๐ฐ Slovakia
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
MH Guide
Device
EU IVDR
·
Eu Ivd Class C
·Molecular Health GmbH·On the market·2 countries
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country