Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
ALBUMIN INCL. UALBUMIN RT & POC
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-CNM0000180725001MR
- Basic UDI-DI Code
- B-CNM0000180725001MR
- Reference
- 5001C 5001S 5001D 5001B
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Shanghai Chemtron Biotech Co., Ltd.
Additional Description
One-Step Microalbuminuria(MAU) Test is made for the rapid detection of microalbuminuria (MAU) in urine specimens. This test kit is used as an aid in indicating of incipient nephropathy and for increased risk of cardiovascular complications such as insulin-dependent diabetes mellitus(IDDM) and non-insulin-dependent diabetes mellitus(NIDM). It is intended for self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160101 | ALBUMIN INCL. UALBUMIN RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 076482 0004 | TÜV SÜD Product Service GmbH | Expired |
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