EU Manufacturer
🇺🇸 United States
Active
CoaguSense Inc.
SRN: US-MF-000026989
·
Fremont Blvd. 48377, 94538 Fremont, United States
Basic UDI-DIs
4
Total Devices
4
On Market
4
Off Market
0
Certificates
3
Valid
0
Expiring < 6mo
3
Countries
0
Basic Information
- Address
- Fremont Blvd. 48377, 94538 Fremont, United States
- [email protected]
- Phone
- 5103358514
- Website
- www.coag-sense.com
Regulatory Overview
Regulation
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Eu Ivdd
4
Classification
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Eu Ivd General
4
Device Types
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Certificate Health
Total
3
Valid
0
Expiring < 6mo
3
Expired / Withdrawn
0
Certificates by Expiry Year
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Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Coag-Sense Control Test Strip Kit - 10 Count | EU IVDD | Eu Ivd General | On Market | 1 |
| Coag-Sense Prothrombin Time (PT) /INR Monitoring System | EU IVDD | Eu Ivd General | On Market | 1 |
| Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit | EU IVDD | Eu Ivd General | On Market | 1 |
| Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit | EU IVDD | Eu Ivd General | On Market | 1 |