Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
GlucoSure HT
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
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Basic Information
- Primary DI
- D-47136487602A05N
- Basic UDI-DI Code
- B-47136487602A05N
- Reference
- S70385
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
GlucoSure HT Blood Glucose Monitoring System is intended for quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm at specific points in time. It is designed for both home use by an individual and for use by healthcare professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010213 | GLUCOSE |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2100077-1 | TÃœV Rheinland LGA Products GmbH | Expired |
Available In Countries
🇨🇾 Cyprus
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