Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
Free Prostate Specific Antigen (f-PSA) Diagnostic Kit
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06971348762179
- Basic UDI-DI Code
- B-06971348762179
- Reference
- MF-47-25
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Shenzhen Microprofit Biotech Co., Ltd.
Additional Description
The fluorecare® f-PSA is applicable to the quantitative detection of the concentration of f-PSA in human serum or plasma.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030114 | FREE PROSTATIC SPECIFIC ANTIGEN |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 109172 0002 Rev. 00 | TÜV SÜD Product Service GmbH | Expired |
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