Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
ACCU-ANSWER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-697191378-TCTSHS
- Basic UDI-DI Code
- B-697191378-TCTSHS
- Reference
- TC01
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Guilin Royalyze Medical Instrument Co., Ltd.
Additional Description
ACCU-ANSWER®isaw® Total Cholesterol Test Strips are used with the ACCU-ANSWER®isaw® Multi-Monitoring Meter for quantitatively measuring total cholesterol in fresh capillary whole blood or Venous blood. ACCU-ANSWER®isaw® Total Cholesterol Test Strips are intended for self-testing outside the body (in vitro diagnostic use) by people at home and health care professionals in the clinical setting.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060102 | CHOLESTEROL TEST STRIPS |
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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