Authorized Representative
🇮🇪 Ireland
Active
Abbott Rapid Dx International Limited
SRN: IE-AR-000000091
·
Parkmore East Business Park, H91 VK7E Galway, Ireland
Manufacturers
5
Devices
4
Certificates
2
PRRCs
2
Basic Information
- Address
- Parkmore East Business Park, H91 VK7E Galway, Ireland
- [email protected]
- Phone
- +35391429932
- Website
- www.abbott.com
- VAT Number
- IE9786150K
- Trade Register
- 495964
- EORI
- IE9786150K
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Axis-Shield Diagnostics Ltd | 🇬🇧 United Kingdom | GB-MF-000001886 |
| Alere San Diego, Inc. | 🇺🇸 United States | US-MF-000008348 |
| Abbott Diagnostics Scarborough, Inc. | 🇺🇸 United States | US-MF-000014444 |
| Abbott Toxicology Ltd | 🇬🇧 United Kingdom | GB-MF-000001885 |
| Abbott Diagnostics Medical Co., Ltd. | 🇯🇵 Japan | JP-MF-000009543 |
| Immunalysis Corporation | 🇺🇸 United States | US-MF-000001555 |
Manufacturers
Abbott Diagnostics Scarborough, Inc.
Manufacturer
🇺🇸 United States·1 Importer
Abbott Toxicology Ltd
Manufacturer
1 Importer
Abbott Diagnostics Medical Co., Ltd.
Manufacturer
🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH
Alere San Diego, Inc.
Manufacturer
🇺🇸 United States·1 Importer
Axis-Shield Diagnostics Ltd
Manufacturer
2 Importers
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| IVDD Annex IV Section 4 | V7 103108 0005 | Abbott Diagnostics Medical Co., Ltd. | TÜV SÜD Product Service GmbH | Expired |
| IVDD Annex IV Section 4 | V7 103108 0007 | Abbott Diagnostics Medical Co., Ltd. | TÜV SÜD Product Service GmbH | Expired |
Devices
HIV AG/AB COMBI - RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·On the market·15 countries
Determine
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·On the market
BLOOD COLLECTION, CAPILLARY TUBES
Device
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·On the market
BUFFERS
Device
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·On the market