EU Manufacturer
🇺🇸 United States
Active
Nonin Medical, Inc.
SRN: US-MF-000008228
·
1st Avenue North 13700, 55441-5443 Plymouth, United States
Basic UDI-DIs
252
Total Devices
252
On Market
252
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
18
Basic Information
- Address
- 1st Avenue North 13700, 55441-5443 Plymouth, United States
- [email protected]
Regulatory Overview
Regulation
Loading...
Eu Mdd
252
Classification
Loading...
Eu Md Class 2b
252
Device Types
Loading...
Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 024497 0030 | TÜV SÜD Product Service GmbH | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | PalmSat Pulse Oximeter System | TÜV SÜD Product Service GmbH | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | Wrist-Worn Pulse Oximeter | TÜV SÜD Product Service GmbH | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | G1 024497 0030 | TÜV SÜD Product Service GmbH | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 18 countries across Europe.
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇺 Hungary
🇮🇹 Italy
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Flexiwrap Adhesive Strips | EU MDD | Eu Md Class 2b | On Market | 1 |
| 3150SC | EU MDD | Eu Md Class 2b | On Market | 1 |
| 6000CA | EU MDD | Eu Md Class 2b | On Market | 1 |
| 7000A | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000AA Reusable Finger Sensor | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000Q2 Reusable Ear Clip Pulse Oximetry Sensor | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000R Reusable Reflectance Pulse Oximetry Sensor | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SM | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SM | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SM | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SM | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SM-WO2 | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SM-WO2 | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SS | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SS | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SS | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SS | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8000SS2 | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8008J Infant Flex Sensor | EU MDD | Eu Md Class 2b | On Market | 1 |
| 9590 | EU MDD | Eu Md Class 2b | On Market | 1 |
| 9590 | EU MDD | Eu Md Class 2b | On Market | 1 |
| Adult/ Pediatric Fiber Optic Sensor | EU MDD | Eu Md Class 2b | On Market | 1 |
| Adult/ Pediatric Fiber Optic Sensor | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System with Waveform | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System with Waveform | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant Pulse Oximeter System with Waveform | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant® 9600 Pulse Oximeter | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant® 9600 Pulse Oximeter | EU MDD | Eu Md Class 2b | On Market | 1 |
| Avant® 9600 Pulse Oximeter | EU MDD | Eu Md Class 2b | On Market | 1 |
| Disposable Cloth Pulse Oximetry Sensors | EU MDD | Eu Md Class 2b | On Market | 1 |
| Disposable Cloth Pulse Oximetry Sensors | EU MDD | Eu Md Class 2b | On Market | 1 |
| Disposable Cloth Pulse Oximetry Sensors | EU MDD | Eu Md Class 2b | On Market | 1 |
| FINGERTIP PULSE OXIMETER with 9590 BLUE, OXIMETER | EU MDD | Eu Md Class 2b | On Market | 1 |
| FINGERTIP PULSE OXIMETER with 9590 RED, OXIMETER | EU MDD | Eu Md Class 2b | On Market | 1 |