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-47136487612AKS25
- Basic UDI-DI Code
- B-47136487612AKS25
- Reference
- S5800269
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The purpose of the control solution test is to validate the performance of the MultiSure GK Blood Ketone Test Strip in MultiSure GK Blood Glucose and Ketone Monitoring System using a testing solution with a known range of ketone. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly. The system used together with the control solution is plasma calibrated.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
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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