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Capnostat 5 LFLO - EUDAMED Registration 00884838082281

Access comprehensive regulatory information for Capnostat 5 LFLO 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 00884838082281 and manufactured by Respironics Novametrix, LLC in United States.

This page provides complete registration details including trade name (LoFlo Sidestream CO2 Module), 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.

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EUDAMED Official Data
Class IIa
00884838082281
No
Capnostat 5 LFLO
Trade Name: LoFlo Sidestream CO2 Module
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Device Description (EMDN)

GASEOUS EXCHANGE MONITORING INSTRUMENTS – OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z1203020499
Trade Name
LoFlo Sidestream CO2 Module
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
00884838082281
Basic UDI
0884838BM632T5
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
3000 Minuteman Road Andover
Email
eudamed@philips.com
Authorized Representative
SRN
DE-AR-000006164
Country
Germany
Address
17 Gewerbestrasse Herrsching am Ammersee
Email
EU.Auth.Rep@philips.com
Telephone
n/a
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Austria
Market Available
Austria:2023-09-14~9999-12-31, Belgium:2023-09-14~9999-12-31, Cyprus:2023-09-14~9999-12-31, Germany:2023-09-14~9999-12-31, Denmark:2023-09-14~9999-12-31, Finland:2023-09-14~9999-12-31, France:2023-09-14~9999-12-31, Greece:2023-09-14~9999-12-31, Hungary:2023-09-14~9999-12-31, Ireland:2023-09-14~9999-12-31, Iceland:2023-09-14~9999-12-31, Italy:2023-09-14~9999-12-31, Liechtenstein:2023-09-14~9999-12-31, Luxembourg:2023-09-14~9999-12-31, Latvia:2023-09-14~9999-12-31, Malta:2023-09-14~9999-12-31, Netherlands:2023-09-14~9999-12-31, Norway:2023-09-14~9999-12-31, Sweden:2023-09-14~9999-12-31, Slovenia:2023-09-14~9999-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No