Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
SPECIFIC PROTEINS RT & POC - OTHER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-CNM0000180729001NM
- Basic UDI-DI Code
- B-CNM0000180729001NM
- Reference
- 9001C 9001S
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Shanghai Chemtron Biotech Co., Ltd.
Additional Description
Fecal Occult Blood Test is useful to detect human hemoglobin found in a number of gastrointestinal disorders, e. g. diverticulitis, colitis, polyps, and colorectal cancer. It is intended for self-testing by laypersons as an aid in the diagnosis of lower gastrointestinal disorders.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160199 | SPECIFIC PROTEINS RT & POC - OTHER |
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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