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-01B0212YD
- Basic UDI-DI Code
- B-01B0212YD
- Reference
- 4B003
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Uric Acid Test Strip is used to quantitatively measure uric acid in human capillary whole blood samples or in venous samples. It is intended for use outside the body only (in vitro diagnostic use) for self-testing or professional use as an aid in the management of hyperuricemia (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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