Pure Global

Trilogy 200 - EUDAMED Registration 00606959033849

Access comprehensive regulatory information for Trilogy 200 in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 00606959033849 and manufactured by Respironics Inc. in United States.

This page provides complete registration details including trade name (Trilogy 200 Ventilator, Intl-Rental), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class IIb
00606959033849
Yes
Trilogy 200
Trade Name: Trilogy 200 Ventilator, Intl-Rental
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

PULMONARY VENTILATORS FOR NON–HOSPITAL USE

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z12030103
Trade Name
Trilogy 200 Ventilator, Intl-Rental
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00606959033849
Basic UDI
B-00606959033849
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
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
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Austria
Market Available
Poland:2010-01-14~9999-12-31, Portugal:2010-01-14~9999-12-31, Romania:2010-01-14~9999-12-31, Sweden:2010-01-14~9999-12-31, Slovenia:2010-01-14~9999-12-31, Slovakia:2010-01-14~9999-12-31, Austria:2010-01-14~9999-12-31, Belgium:2010-01-14~9999-12-31, Cyprus:2010-01-14~9999-12-31, Czechia:2010-01-14~9999-12-31, Germany:2010-01-14~9999-12-31, Denmark:2010-01-14~9999-12-31, Estonia:2010-01-14~9999-12-31, Spain:2010-01-14~9999-12-31, Finland:2010-01-14~9999-12-31, France:2010-01-14~9999-12-31, Greece:2010-01-14~9999-12-31, Croatia:2010-01-14~9999-12-31, Hungary:2010-01-14~9999-12-31, Ireland:2010-01-14~9999-12-31, Iceland:2010-01-14~9999-12-31, Italy:2010-01-14~9999-12-31, Lithuania:2010-01-14~9999-12-31, Luxembourg:2010-01-14~9999-12-31, Latvia:2010-01-14~9999-12-31, Netherlands:2010-01-14~9999-12-31, Norway:2010-01-14~9999-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No