Eu Ivdd
Eu Ivd Self Testing
On The Market
๐น๐ผ Taiwan
THE EDGE
Devices (same UDI-DI)
1
Certificates
1
Countries
6
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487610ALSZP
- Basic UDI-DI Code
- B-47136487610ALSZP
- Reference
- S5800024
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The purpose of the control solution test is to validate the performance of THE EDGE Blood Lactate Monitoring System using a standard solution with a known range of lactate. A control solution test that falls within the acceptable range means the user's technique is an appropriate and both of the meter and test strip are functioning properly.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2100077-1 | TรV Rheinland LGA Products GmbH | Expired |
Available In Countries
๐ง๐ช Belgium
๐ซ๐ฎ Finland
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
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