Eu Ivdd
Eu Ivd Self Testing
No Longer On The Market
🇹🇼 Taiwan
KET-1
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487609A06R
- Basic UDI-DI Code
- B-47136487609A06R
- Reference
- S11004, S11008, S11009
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- No Longer On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The KET-1 Blood Ketone Monitoring System is intended to quantitatively measure blood ketone in venous whole blood or capillary whole blood. The KET-1 Blood Ketone Test Strip is plasma-calibrated for easy comparison to lab results. It is intended for self-testing by people with diabetes or for healthcare professionals use. It is not indicated for the diagnosis or screening of diabetes or for neonate use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060110 | KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) |
| W020106019099 | VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2100077-1 | TÜV Rheinland LGA Products GmbH | Expired |
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