EU Manufacturer
🇺🇸 United States
Active
Passy-Muir, Inc.
SRN: US-MF-000002288
·
Mitchell South 17992, 92614-6813 Irvine, United States
Basic UDI-DIs
6
Total Devices
6
On Market
6
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
18
Basic Information
- Address
- Mitchell South 17992, 92614-6813 Irvine, United States
- [email protected]
- Phone
- 9498338255
- Website
- www.passymuir.com
Regulatory Overview
Regulation
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Eu Mdd
6
Classification
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Eu Md Class 2a
6
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | 252.364 | National Standards Authority of Ireland (NSAI) | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 18 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇺 Luxembourg
🇳🇱 Netherlands
🇵🇹 Portugal
🇸🇪 Sweden
🇹🇷 Türkiye
🇬🇧 United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| PASSY-MUIRâ„¢ LOW PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMVâ„¢ 2000 (clear) | EU MDD | Eu Md Class 2a | On Market | 1 |
| PASSY-MUIRâ„¢ LOW PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMVâ„¢ 2001 (Purple Colorâ„¢) | EU MDD | Eu Md Class 2a | On Market | 1 |
| PASSY-MUIRâ„¢ LOW PROFILE TRACHEOSTOMY SWALLOWING AND SPEAKING VALVE PMVâ„¢ 2020 (clear) | EU MDD | Eu Md Class 2a | On Market | 1 |
| PASSY-MUIRâ„¢ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMVâ„¢ 005 (white) | EU MDD | Eu Md Class 2a | On Market | 1 |
| PASSY-MUIRâ„¢ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMVâ„¢ 007 (Aqua Colorâ„¢) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Passy-Muirâ„¢ Valve Oxygen Adapter (PMAâ„¢ 2000) | EU MDD | Eu Md Class 2a | On Market | 1 |