Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Hemoglobin Monitoring meter
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06939663973007
- Basic UDI-DI Code
- B-06939663973007
- Reference
- HB-101,HB-201,HB-202
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Sejoy Biomedical Co., Ltd.
Additional Description
The Sejoy hemoglobin Meters are used with the Sejoy Test Strips to quantitative measuring hemoglobin content with fresh capillary wholeblood from the finger or venous blood. The hemoglobin Meters can be used for self-testing at home or for professional use.The product is for in vitro diagnostic use only.It can not be used as the only basis for the diagnosis of anemia.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02020699 | RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER |
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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