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OmniLab Connect - EUDAMED Registration 00606959021501

Access comprehensive regulatory information for OmniLab Connect in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00606959021501 and manufactured by Respironics Inc. in United States.

This page provides complete registration details including trade name (OmniLab Connect System), 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 I
00606959021501
Yes
OmniLab Connect
Trade Name: OmniLab Connect System
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Device Description (EMDN)

VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12159082
Trade Name
OmniLab Connect System
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00606959021501
Basic UDI
0606959BM210LH
Version Date
February 26, 2025
Manufacturer Last Update
May 21, 2024
Active Status
Yes
Manufacturer
Manufacturer Name
Respironics Inc.
Country
United States
Country Type
NON_EU
Address
1001 Murry Ridge Lane Murrysville
Email
eudamed@philips.com
Authorized Representative
SRN
NL-AR-000001422
Country
Netherlands
Address
6 Veenpluis Best
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:2013-01-10~9999-12-31, Belgium:2013-01-10~9999-12-31, Cyprus:2013-01-10~9999-12-31, Czechia:2013-01-10~9999-12-31, Germany:2013-01-10~9999-12-31, Denmark:2013-01-10~9999-12-31, Estonia:2013-01-10~9999-12-31, Spain:2013-01-10~9999-12-31, Finland:2013-01-10~9999-12-31, France:2013-01-10~9999-12-31, Greece:2013-01-10~9999-12-31, Croatia:2013-01-10~9999-12-31, Hungary:2013-01-10~9999-12-31, Ireland:2013-01-10~9999-12-31, Iceland:2013-01-10~9999-12-31, Italy:2013-01-10~9999-12-31, Lithuania:2013-01-10~9999-12-31, Luxembourg:2013-01-10~9999-12-31, Latvia:2013-01-10~9999-12-31, Netherlands:2013-01-10~9999-12-31, Norway:2013-01-10~9999-12-31, Poland:2013-01-10~9999-12-31, Portugal:2013-01-10~9999-12-31, Romania:2013-01-10~9999-12-31, Sweden:2013-01-10~9999-12-31, Slovenia:2013-01-10~9999-12-31, Slovakia:2013-01-10~9999-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No