Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-01B0206YJ
- Basic UDI-DI Code
- B-01B0206YJ
- Reference
- 1V003
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Safe AQ UG uric acid test strip is used only with Safe AO UG，EA-12 meters to quantitative determine uric acid in human capillary whole blood samples or in the venous samples.It is intended for use outside the body only (in vitro imme diagnostic use) for self testing or professional use as an other aid in the management of hypeuricemia (HUA).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060199 | BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 060250 0017 | TÜV SÜD Product Service GmbH | Expired |
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