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EUDAMED registration 00849686098693Yes

PalmSat Pulse Oximeter System

Nonin Medical, Inc.Class IIbEU EUDAMEDTrade name: Pulse Oximeter System
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIb
CND nomenclatures code
Z1203020408
Trade name
Pulse Oximeter System
Implantable
No
Reusable
No
Measuring function
Yes
Registration information
Primary DI
00849686098693
Basic UDI
B-00849686098693
Version date
December 12, 2024
Manufacturer last update
October 31, 2023
Active status
Yes
Manufacturer
Manufacturer name
Nonin Medical, Inc.
Country
United States
Country type
NON_EU
Address
13700 1st Avenue North Plymouth
Email
regulatory@nonin.com
Authorized representative
Name
MPS Medical Product Service GmbH
SRN
DE-AR-000005009
Country
Germany
Address
20 Borngasse Braunfels
Email
g.froemel@mps-gmbh.eu
Telephone
+49 6442962073
Regulatory information
Competent authority
DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Netherlands
Market available
Czechia:2014-07-21~None, Denmark:2014-07-21~None, Finland:2014-07-21~None, France:2014-07-21~None, Germany:2014-07-21~None, Greece:2014-07-21~None, Hungary:2014-07-21~None, Italy:2014-07-21~None, Netherlands:2014-07-21~None, Norway:2014-07-21~None, Poland:2014-07-21~None, Portugal:2014-07-21~None, Romania:2014-07-21~None, Slovakia:2014-07-21~None, Slovenia:2014-07-21~None, Spain:2014-07-21~None, Sweden:2014-07-21~None, Türkiye:2014-07-21~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

PULSE OXIMETERS

About this record

Access comprehensive regulatory information for PalmSat Pulse Oximeter System 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 00849686098693 and manufactured by Nonin Medical, Inc. in United States.

This page provides complete registration details including trade name (Pulse Oximeter System), manufacturer information, authorized representative details, competent authority (DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I), 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.