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EUDAMED registration M766AS2002R0Yes

Freestyle Comfort

CAIRE Inc.Class IIaEU EUDAMEDTrade name: Freestyle Comfort
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Z12159004
Trade name
Freestyle Comfort
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
M766AS2002R0
Basic UDI
B-M766AS2002R0
Version date
February 24, 2025
Manufacturer last update
September 24, 2024
Active status
Yes
Manufacturer
Manufacturer name
CAIRE Inc.
Country
United States
Country type
NON_EU
Address
2200 Airport Industrial drive Ball Ground
Email
pamela.netzel@caireinc.com
Authorized representative
Name
MPS Medical Product Service GmbH
SRN
DE-AR-000005009
Country
Germany
Address
20 Borngasse Braunfels
Email
g.froemel@mps-gmbh.eu
Telephone
+49 6442962073
Regulatory information
Competent authority
DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Germany
Market available
Germany:None~2028-12-31
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

OXYGEN CONCENTRATORS

About this record

Access comprehensive regulatory information for Freestyle Comfort 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 M766AS2002R0 and manufactured by CAIRE Inc. in United States.

This page provides complete registration details including trade name (Freestyle Comfort), manufacturer information, authorized representative details, competent authority (DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I), 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.