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EUDAMED registration 05700571108697No

GenetiSure Dx Postnatal Assay

Agilent Technologies, Inc.Class CEU EUDAMEDTrade name: GenetiSure Dx Postnatal Assay
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class C
CND nomenclatures code
W01060299
Trade name
GenetiSure Dx Postnatal Assay
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
05700571108697
Basic UDI
570057R0403P3011C040000N8
Version date
June 20, 2024
Manufacturer last update
October 15, 2021
Active status
No
Manufacturer
Manufacturer name
Agilent Technologies, Inc.
Country
United States
Country type
NON_EU
Address
5301 Stevens Creek Blvd. Santa Clara
Email
info.dk@agilent.com
Authorized representative
Name
Agilent Technologies Denmark ApS
SRN
DK-AR-000001443
Country
Denmark
Address
42 Produktionsvej Glostrup
Email
info.dk@agilent.com
Telephone
+45 44 85 95 00
Regulatory information
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
Market available
Denmark:2022-05-16~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

About this record

Access comprehensive regulatory information for GenetiSure Dx Postnatal Assay in the European Union medical device market through Pure Global AI's free database. This Class C device is registered with EU EUDAMED under Primary DI 05700571108697 and manufactured by Agilent Technologies, Inc. in United States.

This page provides complete registration details including trade name (GenetiSure Dx Postnatal Assay), 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.