Notified Body
NB 0086
🇬🇧 United Kingdom
BSI Assurance UK Ltd
Kitemark Court Davy Avenue Knowlhill, 8PP Milton Keynes, United Kingdom
View on EUDAMED
Updated Oct 1, 2021
Certificates
3
Valid
0
Expiring < 6mo
3
Expired
0
Basic UDI-DIs
4
Devices
4
Manufacturers
1
Cert. Types
1
Basic Information
- Address
- Kitemark Court Davy Avenue Knowlhill, 8PP Milton Keynes, United Kingdom
- [email protected]
- Phone
- 44 (0) 8450 809000
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Expired / Withdrawn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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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | MD 662930 | CoaguSense Inc. | Jun 20, 2026 | |||
| IVDD Annex IV (excluding sections 4, 6) | 0086 | CoaguSense Inc. | Jun 20, 2026 | |||
| IVDD Annex IV (excluding sections 4, 6) | MD662930 | CoaguSense Inc. | Jun 20, 2026 |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| CoaguSense Inc. | 🇺🇸 United States | 3 | 0 | 3 |