GlucoSure HT Link
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- D-47136487602A15Q
- Basic UDI-DI Code
- B-47136487602A15Q
- Reference
- S70440, S70441, S70442
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- No Longer On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The GlucoSure HT Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is indicated for self-testing use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0101060101 | GLUCOSE TEST STRIPS |
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2100077-1 | TÜV Rheinland LGA Products GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).