Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
π°π· South Korea
FREND PSA Plus
Devices (same UDI-DI)
1
Certificates
1
Countries
6
Notified Bodies
1
Basic Information
- Primary DI
- 08809317540481
- Basic UDI-DI Code
- B-08809317540481
- Reference
- FRPS 025
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- NanoEntek, Inc.
Additional Description
The FREND PSA Plus is designed for in vitro diagnostic use only for the quantitative measurement of total prostate specific antigen (PSA) in human serum, heparinized plasma and EDTA plasma using the FREND System. This device is indicated for the serial measurement of total PSA in serum, heparinized plasma and EDTA plasma to be used as an aid in the management of patients with prostate cancer.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030113 | TOTAL PROSTATIC SPECIFIC ANTIGEN |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 064393 0011 | TΓV SΓD Product Service GmbH | Expired |
Available In Countries
π¨πΎ Cyprus
π©πͺ Germany
πͺπΈ Spain
π«π· France
π±πΉ Lithuania
π·π΄ Romania
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