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EUDAMED registration 00814848020485Yes

MRI RF Coils

Quality Electrodynamics, LLCClass IIaEU EUDAMEDTrade name: 16ch T/R Hand Wrist Coil
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Z11059080
Trade name
16ch T/R Hand Wrist Coil
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00814848020485
Basic UDI
081484802RFCOILBV
Version date
November 30, 2023
Manufacturer last update
February 15, 2021
Active status
Yes
Manufacturer
Manufacturer name
Quality Electrodynamics, LLC
Country
United States
Country type
NON_EU
Address
6655 Beta Drive Mayfield Village
Email
kathleen.aras@qualedyn.com
Authorized representative
Name
Emergo Europe B.V.
SRN
NL-AR-000000116
Country
Netherlands
Address
60 Westervoortsedijk Arnhem
Email
lst.aus.euauthrep@ul.com
Telephone
+31 70 345 8570
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Netherlands
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, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES

About this record

Access comprehensive regulatory information for MRI RF Coils in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00814848020485 and manufactured by Quality Electrodynamics, LLC in United States.

This page provides complete registration details including trade name (16ch T/R Hand Wrist Coil), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.