EU Manufacturer
🇺🇸 United States
Active
Respironics Inc.
SRN: US-MF-000002301
·
Murry Ridge Lane 1001, 15668 Murrysville, United States
Basic UDI-DIs
237
Total Devices
285
On Market
285
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
31
Basic Information
- Address
- Murry Ridge Lane 1001, 15668 Murrysville, United States
- [email protected]
- Phone
- n/a
- Website
- n/a
Regulatory Overview
Regulation
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Eu Mdd
219
Eu Mdr
18
Classification
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Eu Md Class 2a
174
Eu Md Class 2b
36
Eu Md Class 1
27
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 015581 0611 | TÜV SÜD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 015581 0608 | TÜV SÜD Product Service GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 31 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| (10) BiPAP Disposable Humidifier Tubing 36 IN (91cm) | EU MDD | Eu Md Class 2a | On Market | 1 |
| (10) Disposable Proximal Pressure Line Assembly | EU MDD | Eu Md Class 2a | On Market | 1 |
| A40 Pro/EFL Detachable Battery Module, Rental | EU MDR | Eu Md Class 1 | On Market | 0 |
| AIR FLOW,CANNULA SAMPLE PACK | EU MDD | Eu Md Class 1 | On Market | 0 |
| ALICE PDX Portable Sleep Diagnostic System International | EU MDD | Eu Md Class 2a | On Market | 1 |
| ALICE PDx Diagnostic System International, Rental | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Sanifit SNFCT2020-07 Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Sanifit SNFCT2020-07 Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Angelini 152PO17433 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Bayer 20887 Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Bayer 20887 Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Immusoft MT2018-18 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Insmed INS 415 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Insmed INS 415 Pkg Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Insmed INS 416 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Insmed INS 416 Pkg Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Janssen 42756493BLC3001 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Janssen 42847922MDD1005 Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Janssen 42847922MDD1005 Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Janssen 42847922MDD3001 Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Janssen 42847922MDD3001 Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Janssen CNTO1275CRD3007 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Janssen NOPRODBIP0001 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Kiniksa KPL-716-C001 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Kiniksa KPL-OBS001 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Koneksa Pkg LPS16677 Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT MT-8554-E06 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Novartis CAIN457FUS06 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Ovid OV101-17-001 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Ovid OV101-17-002 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Regeneron R3500-AD-1798 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Roche BP29937 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT TAK-994-1503 Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT TAK-994-1503 Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Takeda TAK-925-2001 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Takeda TAK-925-2001 Pkg Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Takeda TAK-925-2002 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Takeda TAK-994-1501 Pkg Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Ultragenyx UX701-CL001 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Ultragenyx UX701-CL001 Pkg Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Vanda VP-VEC-162-3502 Pkg Scorer | EU MDD | Eu Md Class 2a | On Market | 1 |
| AW CT Vanda VP-VEC-162-3502 Pkg Site | EU MDD | Eu Md Class 2a | On Market | 1 |
| Actical Software | EU MDD | Eu Md Class 2a | On Market | 1 |
| Actical-Recertified | EU MDD | Eu Md Class 2a | On Market | 1 |
| Actical-Rental | EU MDD | Eu Md Class 2a | On Market | 1 |
| Actiware Clinical Trial Software, English - 6 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Actiware Software CD - 6 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Actiware Software Pkg., Addl License BOM | EU MDD | Eu Md Class 2a | On Market | 1 |
| Actiware Software Web Download - 6 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Actiwatch Spectrum Device | EU MDD | Eu Md Class 2a | On Market | 1 |