Eu Ivdd
Eu Ivd Self Testing
On The Market
🇰🇷 South Korea
CERA-CHEK™ Hb Plus Hemoglobin Test Strip
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800065140022
- Basic UDI-DI Code
- B-08800065140022
- Reference
- B400S10
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
The CERA-CHEK™ Hb Plus Hemoglobin Test Strip is intended for use with the CERA-CHEK™ Hb Plus Hemoglobin Monitoring System for self-testing by lay persons who need to checkup the hemoglobin level or with anemia (especially iron deficiency anemia) and for near-patient testing by healthcare professionals to quantitatively monitor the effectiveness of hemoglobin level control in venous blood and fresh capillary whole blood drawn from the fingertips.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010201 | HAEMOGLOBIN DETERMINATIONS (TOTAL HB) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 091763 0015 | TÜV SÜD Product Service GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).
CERA-CHEK™ Lactate Measuring System
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
CERA-CHEK™ 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