Eu Ivdd
Eu Ivd Self Testing
On The Market
🇹🇼 Taiwan
HemoSmart GOLD
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487606A06A
- Basic UDI-DI Code
- B-47136487606A06A
- Reference
- S25009, S25032, S25033
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The HemoSmart GOLD Hemoglobin Screening System is intended for use outside the body (in vitro diagnostic use) and is useful for quantitative measurement of hemoglobin in the range of 4 g/dL to 24 g/dL in capillary (fingerstick) or venous whole blood. HemoSmart GOLD Hemoglobin Screening System is intended for selftesting for monitoring the health of the patient (e.g. anemias (low Hb), erythrocytosis (high Hb), thalassemias (aberrant chain synthesis), and sickling disorders (abnormal complex shape)) by layperson and by health care professional. It is not indicated for diagnostic use or for neonatal and children use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0101060199 | BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER |
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2100077-1 | TÃœV Rheinland LGA Products GmbH | Expired |
Available In Countries
🇬🇷 Greece
🇫🇮 Finland
🇵🇱 Poland
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).
CERA-CHEKâ„¢ Lactate Measuring System
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
CERA-CHEKâ„¢ Lactate Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
BGI
Device
EU IVDD
·
Eu Ivd Self Testing
·BGI EUROPE A/S·On the market
Lactate Pro 2 (LT-1730)
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market