EUDAMED registration 00849686070453Yes

Pulse Oximeter Probe Single Use

Name: Pulse Oximeter Probe Single Use — EUDAMED registration 00849686070453
Creator: Nonin Medical, Inc.
Keywords: Pulse Oximeter Probe Single Use, 00849686070453, Pulse Oximeter Probe Single Use, Class IIb, Nonin Medical, Inc., EUDAMED registration

Nonin Medical, Inc.Class IIbEU EUDAMEDTrade name: Pulse Oximeter Probe Single Use

VerifiedEUDAMED · official EU database

Device classification

Risk class: Class IIb
CND nomenclatures code: C900301
Trade name: Pulse Oximeter Probe Single Use
Implantable: No
Reusable: No
Measuring function: Yes

Registration information

Primary DI: 00849686070453
Basic UDI: B-00849686070453
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:2013-05-01~None, Denmark:2013-05-01~None, Finland:2013-05-01~None, France:2013-05-01~None, Germany:2013-05-01~None, Greece:2013-05-01~None, Hungary:2013-05-01~None, Italy:2013-05-01~None, Netherlands:2013-05-01~None, Norway:2013-05-01~None, Poland:2013-05-01~None, Portugal:2013-05-01~None, Romania:2013-05-01~None, Slovakia:2013-05-01~None, Slovenia:2013-05-01~None, Spain:2013-05-01~None, Sweden:2013-05-01~None, Türkiye:2013-05-01~None

Device characteristics

Human tissues: No
Animal tissues: No

Device description (EMDN)

PULSE OXIMETER SENSORS

About this record

Access comprehensive regulatory information for Pulse Oximeter Probe Single Use 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 00849686070453 and manufactured by Nonin Medical, Inc. in United States.

This page provides complete registration details including trade name (Pulse Oximeter Probe Single Use), 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.