EUDAMED registration 05700571112656NoGenetiSure Dx Universal aCGH Reagents
- Risk class
- Class A
- CND nomenclatures code
- W0599
- Trade name
- GenetiSure Dx Cot-1 Human DNA
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 05700571112656
- Basic UDI
- 570057R0801P3011A040100QM
- Version date
- June 28, 2024
- Manufacturer last update
- October 15, 2021
- Active status
- No
- Manufacturer name
- Agilent Technologies, Inc.
- Country
- United States
- Country type
- NON_EU
- Address
- 5301 Stevens Creek Blvd. Santa Clara
- info.dk@agilent.com
- SRN
- DK-AR-000001443
- Country
- Denmark
- Address
- 42 Produktionsvej Glostrup
- info.dk@agilent.com
- Telephone
- +45 44 85 95 00
- Competent authority
- Danish Medicines Agency, Pharmacovigilance & Medical Devices
- Applicable legislation
- IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
- Placed on the market
- Denmark
- Human tissues
- Yes
- Animal tissues
- Yes
IVD GENERAL USE CONSUMABLE DEVICES - OTHER
Access comprehensive regulatory information for GenetiSure Dx Universal aCGH Reagents in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 05700571112656 and manufactured by Agilent Technologies, Inc. in United States.
This page provides complete registration details including trade name (GenetiSure Dx Cot-1 Human DNA), manufacturer information, authorized representative details, competent authority (Danish Medicines Agency, Pharmacovigilance & Medical Devices), 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.