IMMAGE Immunochemistry Systems PAB Prealbumin Reagent
- Risk class
- Class B
- CND nomenclatures code
- W0102010305
- Trade name
- IMMAGE Immunochemistry Systems PAB Prealbumin Reagent
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 15099590231897
- Basic UDI
- 150995901447440L5
- Version date
- April 26, 2024
- Manufacturer last update
- July 21, 2021
- Active status
- No
- Manufacturer name
- Beckman Coulter Inc.
- Country
- United States
- Country type
- NON_EU
- Address
- 250 S Kraemer Blvd Brea, CA
- BECFA@beckman.com
- SRN
- IE-AR-000000886
- Country
- Ireland
- Address
- Lismeehan Clare
- ra.clare@beckman.com
- Telephone
- +353 65 6831100
- Competent authority
- Health Products Regulatory Authority, Medical Devices Department
- Applicable legislation
- IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
- Placed on the market
- Ireland
- Market available
- Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
- Human tissues
- Yes
- Animal tissues
- Yes
PRE-ALBUMIN / TRANSTHYRETIN
Access comprehensive regulatory information for IMMAGE Immunochemistry Systems PAB Prealbumin Reagent in the European Union medical device market through Pure Global AI's free database. This Class B device is registered with EU EUDAMED under Primary DI 15099590231897 and manufactured by Beckman Coulter Inc. in United States.
This page provides complete registration details including trade name (IMMAGE Immunochemistry Systems PAB Prealbumin Reagent), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.