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

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Expired / Withdrawn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 Jun 20, 2026
IVDD Annex IV (excluding sections 4, 6) 0086 Jun 20, 2026
IVDD Annex IV (excluding sections 4, 6) MD662930 Jun 20, 2026

Manufacturer Portfolio

Manufacturer Certificates
CoaguSense Inc. 3