Notified Body
NB 0050
🇮🇪 Ireland
National Standards Authority of Ireland (NSAI)
1 Swift Square, Northwood, Santry, Dublin 9, Ireland
View on EUDAMED
Updated May 30, 2024
Certificates
34
Valid
0
Expiring < 6mo
0
Expired
18
Basic UDI-DIs
263
Devices
263
Manufacturers
14
Cert. Types
3
Basic Information
- Address
- 1 Swift Square, Northwood, Santry, Dublin 9, Ireland
- [email protected]
- Phone
- +353.1.807.38.00
- Website
- www.nsai.ie
Regulatory Overview
Regulation
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Eu Mdd
263
Classification
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Eu Md Class 3
131
Eu Md Class 1
77
Eu Md Class 2a
54
Eu Md Class 2b
1
Device Types
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Certificate Health
Total
34
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
18
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 252.889 | Delfi Medical Innovations Inc. | Feb 22, 2022 | |||
| MDD Annex II Section 4 | 252.970 | Rompharm Company SRL | Apr 23, 2023 | |||
| MDD Annex II (excluding section 4) | 252.1162 | Blue Spark Technologies, Inc. | Sep 17, 2023 | |||
| MDD Annex II Section 4 | 252.973 | Rompharm Company SRL | Feb 04, 2024 | |||
| MDD Annex II Section 4 | 252.979 | Rompharm Company SRL | Feb 18, 2024 | |||
| MDD Annex II Section 4 | 252.1173 | Rompharm Company SRL | Apr 24, 2024 | |||
| MDD Annex II (excluding section 4) | 252.903 | Syncrophi Systems Ltd | May 26, 2024 | |||
| MDD Annex V | 252.364 | Passy-Muir, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 252.1110 | Alcor Scientific | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 252.954 | Biosensors Europe SA | May 26, 2024 | |||
| MDD Annex V | 252.1234 | Medifill Ltd | May 26, 2024 | |||
| MDD Annex II Section 4 | 252.798 | Graftys | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 252.954 | Biosensors Europe SA | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 252.509 | Aerogen Ltd | May 26, 2024 | |||
| MDD Annex II Section 4 | 252.1251 | Endologix LLC | May 26, 2024 | |||
| MDD Annex II Section 4 | 252.1251 | Endologix LLC | May 26, 2024 | |||
| MDD Annex V | 252.799 | Graftys | May 26, 2024 | |||
| MDD Annex V | 252.1090 | Haemoband Surgical Ltd | May 26, 2024 | |||
| MDD Annex II Section 4 | 252.949 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.901 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.934 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.711 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.807 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.806 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.761 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.943 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.969 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.932 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.962 | Penumbra, Inc. | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | 252.885 | Penumbra, Inc. | Dec 31, 2028 | |||
| MDD Annex V | 252.583 | Advance Medical Designs, Inc. | Dec 31, 2028 | |||
| MDD Annex V | 252.1190 | Advance Medical Designs, Inc. | Dec 31, 2028 | |||
| MDD Annex V | 252.1210 | Advance Medical Designs, Inc. | Dec 31, 2028 | |||
| MDD Annex V | 252.582 | Advance Medical Designs, Inc. | Dec 31, 2028 |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| Penumbra, Inc. | 🇺🇸 United States | 12 | 0 | 0 |
| Rompharm Company SRL | 🇷🇴 Romania | 4 | 0 | 0 |
| Advance Medical Designs, Inc. | 🇺🇸 United States | 4 | 0 | 0 |
| Biosensors Europe SA | 🇨🇭 Switzerland | 2 | 0 | 0 |
| Graftys | 🇫🇷 France | 2 | 0 | 0 |
| Endologix LLC | 🇺🇸 United States | 2 | 0 | 0 |
| Syncrophi Systems Ltd | 🇮🇪 Ireland | 1 | 0 | 0 |
| Passy-Muir, Inc. | 🇺🇸 United States | 1 | 0 | 0 |
| Alcor Scientific | 🇺🇸 United States | 1 | 0 | 0 |
| Medifill Ltd | 🇮🇪 Ireland | 1 | 0 | 0 |
| Aerogen Ltd | 🇮🇪 Ireland | 1 | 0 | 0 |
| Blue Spark Technologies, Inc. | 🇺🇸 United States | 1 | 0 | 0 |
| Haemoband Surgical Ltd | 1 | 0 | 0 | |
| Delfi Medical Innovations Inc. | 🇨🇦 Canada | 1 | 0 | 0 |