Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
ACCU-ANSWER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-697191378-MMQ8
- Basic UDI-DI Code
- B-697191378-MMQ8
- Reference
- LBM-01
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Guilin Royalyze Medical Instrument Co., Ltd.
Additional Description
The ACCU-ANSWER®isaw® Multi-Monitoring System is intended to be used for quantitative measurement of total cholesterol,blood glucose, hemoglobin and uric acid in fresh capillary whole blood and venous whole blood. Test results of total cholesterol,blood glucose , hemoglobin and uric acid are plasmacalibrated. This helps you and your healthcare professional to compare your meter results with laboratory tests.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2156856-1 | TÜV Rheinland LGA Products GmbH | Expired |
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