EU Manufacturer
๐ฐ๐ท South Korea
Active
i-SENS, Inc.
SRN: KR-MF-000009173
ยท
Banpo-daero 28-gil, Seocho-gu 43, 06646 Seoul, South Korea
Basic UDI-DIs
3
Total Devices
4
On Market
4
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Banpo-daero 28-gil, Seocho-gu 43, 06646 Seoul, South Korea
- [email protected]
- Website
- https://i-sens.com/
Regulatory Overview
Regulation
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Eu Mdr
2
Eu Ivdr
1
Classification
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Eu Md Class 1
1
Eu Md Class 2b
1
Eu Ivd Class A
1
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
๐ฉ๐ช Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CareSens Air Continuous Glucose Monitoring System | EU MDR | Eu Md Class 2b | On Market | 0 |
| alphacheck professional Lancing Device | EU MDR | Eu Md Class 1 | On Market | 0 |
| emVia Lancing Device | EU MDR | Eu Md Class 1 | On Market | 0 |
| i-Smart 30 PRO Electrolyte Analyzer | EU IVDR | Eu Ivd Class A | On Market | 0 |