Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Urinary Tract Infections Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06936983105729
- Basic UDI-DI Code
- B-06936983105729
- Reference
- U031-04H
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
Additional Description
The Urinary Tract Infections Test (Urine) is firm plastic strips onto which several separate reagent areas are affixed. The test is for the qualitative detection of the following analytes in urine: Leukocytes, Blood, Nitrite and Protein. The Urinary Tract Infections Test (Urine) is for single use in self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060204 | URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V1095123 0008 | TÜV SÜD Product Service GmbH | Expired |
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