Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
PROTHROMBIN TIME RT & POC
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06953792720134
- Basic UDI-DI Code
- B-06953792720134
- Reference
- HZ-200124
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Helixgen (GUANGZHOU) Co., Ltd.
Additional Description
This product is intended for quantitative measurement of prothrombin time of fresh capillary blood, which may be used for monitoring the coagulation function of patients undertaking oral anticoagulation therapy with Warfarin.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103020801 | PROTHROMBIN TIME RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 105461 0002 | TÜV SÜD Product Service GmbH | Expired |
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