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LiteTouch Face Mask - EUDAMED Registration 00383730000800

Access comprehensive regulatory information for LiteTouch Face Mask 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 00383730000800 and manufactured by Respironics Inc. in United States.

This page provides complete registration details including trade name (LITETOUCH LARGE MASK), 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
00383730000800
No
LiteTouch Face Mask
Trade Name: LITETOUCH LARGE MASK
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Device Description (EMDN)

RESPIRATORY MASKS - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
R030199
Trade Name
LITETOUCH LARGE MASK
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00383730000800
Basic UDI
038373BM262XD
Version Date
February 26, 2025
Manufacturer Last Update
May 21, 2024
Active Status
No
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
Belgium
Market Available
Belgium:2013-07-01~9999-12-31, Germany:2013-07-01~9999-12-31, Austria:2013-07-01~9999-12-31, Cyprus:2013-07-01~9999-12-31, Czechia:2013-07-01~9999-12-31, Denmark:2013-07-01~9999-12-31, Estonia:2013-07-01~9999-12-31, Spain:2013-07-01~9999-12-31, Finland:2013-07-01~9999-12-31, France:2013-07-01~9999-12-31, Greece:2013-07-01~9999-12-31, Croatia:2013-07-01~9999-12-31, Hungary:2013-07-01~9999-12-31, Ireland:2013-07-01~9999-12-31, Iceland:2013-07-01~9999-12-31, Italy:2013-07-01~9999-12-31, Lithuania:2013-07-01~9999-12-31, Luxembourg:2013-07-01~9999-12-31, Latvia:2013-07-01~9999-12-31, Netherlands:2013-07-01~9999-12-31, Norway:2013-07-01~9999-12-31, Poland:2013-07-01~9999-12-31, Portugal:2013-07-01~9999-12-31, Romania:2013-07-01~9999-12-31, Sweden:2013-07-01~9999-12-31, Slovenia:2013-07-01~9999-12-31, Slovakia:2013-07-01~9999-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No