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-47136487612AT83
- Basic UDI-DI Code
- B-47136487612AT83
- Reference
- S5640624, S5640451, S5640452
- 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 Glucose Test Strip is intended to be used with the MultiSure GK Blood Glucose and Ketone Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The MultiSure GK Blood Glucose Test Strip is plasma-calibrated for easy comparison to lab results. It is intended for self-testing by people with diabetes and by healthcare professionals. It is not indicated for the diagnosis
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060101 | GLUCOSE 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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