Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
RAPID TEST HEMOSTASIS INSTRUMENTS
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06953792720141
- Basic UDI-DI Code
- B-06953792720141
- Reference
- HZ-200401
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Helixgen (GUANGZHOU) Co., Ltd.
Additional Description
The HemoPOC® Coagulometer is intended for quantitative measurement of prothrombin time of fresh capillary blood, which may be used for monitoring the coagulation function of patients undergoing oral anticoagulation therapy with Warfarin.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02020602 | RAPID TEST HEMOSTASIS INSTRUMENTS |
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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