Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Hemoglobin Test Strip
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06939663973106
- Basic UDI-DI Code
- B-06939663973106
- Reference
- HS-101
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Sejoy Biomedical Co., Ltd.
Additional Description
The Sejoy hemoglobin test strips are used with HB-101,HB-201 and HB-202 hemoglobin meter as a Hemoglobin Monitoring System to quantitatively measure hemoglobin with capillary from the finger and venous whole blood. The Hemoglobin Monitoring System is intended for professional and self-testing monitoring hemoglobin in vitro diagnostic use only,not used as the sole basis for the judgment of anemic disease.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010601 | HAEMOGLOBIN (HB) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 095295 0002 | TÜV SÜD Product Service GmbH | Expired |
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