Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00861900000398
- Basic UDI-DI Code
- B-00861900000398
- Reference
- 03P56-50
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- CoaguSense Inc.
Additional Description
Coag-Sense PT/INR Test Strip Kit
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103020101 | PROTHROMBIN TIME ( QUICK TEST ) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | MD 662930 | BSI Assurance UK Ltd |
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