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-47136487610ALTZR
- Basic UDI-DI Code
- B-47136487610ALTZR
- Reference
- S5638025
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
THE EDGE Blood Lactate Test Strips are to be used with THE EDGE Blood Lactate Analyzer to quantitatively measure lactate in capillary whole blood. THE EDGETM Blood Lactate Monitoring System is plasmacalibrated for easy comparison to lab result. THE EDGE Blood Lactate Monitoring System is intended for selftesting by persons with chronic diseases (diabetes ,cardiovascular disease, liver diease, muscular dystrophy) and by health care professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060104 | LACTATE TEST STRIPS |
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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