Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
MultiSure GK
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487612AKT27
- Basic UDI-DI Code
- B-47136487612AKT27
- Reference
- S5640465, S5640466
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The MultiSure GK Blood Ketone Test Strip is to be used with the Multisure GK blood glucose and ketone meter to quantitatively measure blood ketone in venous whole blood or capillary whole blood. The MultiSure GK 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 (Î’-HYDROXYBUTYRATE TEST STRIPS) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2100077-1 | TÃœV Rheinland LGA Products GmbH | Expired |
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