Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487604A05Y
- Basic UDI-DI Code
- B-47136487604A05Y
- Reference
- S5640752
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The UASure® Blood Uric Acid Monitoring System is intended for use outside the body (in vitro diagnostic use) in a clinical setting by healthcare professionals and at home by person with Hyperuricemia as an aid to monitor the effectiveness of the medication. The UASure Blood Uric Acid Monitoring System is not intended to diagnose Hyperuricemia or Gout, and results obtained from using the UASure Blood Uric Acid Monitoring System should not be use as a basis to alter medication without first consult a physician or healthcare professional.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010232 | URIC ACID |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2100077-1 | TÜV Rheinland LGA Products GmbH | Expired |
Available In Countries
🇵🇱 Poland
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