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Reusable SpO2 Clips and Single use Grips - EUDAMED Registration 10884838100999

Access comprehensive regulatory information for Reusable SpO2 Clips and Single use Grips 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 10884838100999 and manufactured by Invivo, a division of Philips Medical Systems in United States.

This page provides complete registration details including trade name (Pediatric SpO2 Grips (20)), 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
10884838100999
No
Reusable SpO2 Clips and Single use Grips
Trade Name: Pediatric SpO2 Grips (20)
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Device Description (EMDN)

MULTIโ€“PARAMETER MONITORS - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z1203020299
Trade Name
Pediatric SpO2 Grips (20)
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
10884838100999
Basic UDI
0884838BM453T3
Version Date
February 14, 2025
Manufacturer Last Update
May 21, 2024
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
12151 Research Pkwy Orlando
Email
eudamed@philips.com
Authorized Representative
SRN
DE-AR-000006030
Country
Germany
Address
2 Hewlett-Packard-Strasse Bรถblingen
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:2010-11-18~9999-12-31, Belgium:2010-11-18~9999-12-31, Bulgaria:2010-11-18~9999-12-31, Cyprus:2010-11-18~9999-12-31, Czechia:2010-11-18~9999-12-31, Germany:2010-11-18~9999-12-31, Denmark:2010-11-18~9999-12-31, Estonia:2010-11-18~9999-12-31, Spain:2010-11-18~9999-12-31, Finland:2010-11-18~9999-12-31, France:2010-11-18~9999-12-31, Greece:2010-11-18~9999-12-31, Croatia:2010-11-18~9999-12-31, Hungary:2010-11-18~9999-12-31, Ireland:2010-11-18~9999-12-31, Italy:2010-11-18~9999-12-31, Lithuania:2010-11-18~9999-12-31, Luxembourg:2010-11-18~9999-12-31, Latvia:2010-11-18~9999-12-31, Malta:2010-11-18~9999-12-31, Netherlands:2010-11-18~9999-12-31, Poland:2010-11-18~9999-12-31, Portugal:2010-11-18~9999-12-31, Romania:2010-11-18~9999-12-31, Sweden:2010-11-18~9999-12-31, Slovenia:2010-11-18~9999-12-31, Slovakia:2010-11-18~9999-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No