EU Manufacturer
🇸🇪 Sweden
Active
Breas Medical AB
SRN: SE-MF-000001061
·
Företagsvägen 1, 43533 MÖLNLYCKE, Sweden
Basic UDI-DIs
32
Total Devices
74
On Market
71
Off Market
3
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
25
Basic Information
- Address
- Företagsvägen 1, 43533 MÖLNLYCKE, Sweden
- [email protected]
- Phone
- +4631868800
- Website
- https://www.breas.com/
Regulatory Overview
Regulation
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Eu Mdd
22
Eu Mdr
10
Classification
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Eu Md Class 2a
20
Eu Md Class 2b
11
Eu Md Class 1
1
Device Types
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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Expired / Withdrawn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 II (excluding section 4) | CE683722 | BSI Group The Netherlands B.V. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 25 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇮🇪 Ireland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇺 Luxembourg
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇹🇷 Türkiye
🇬🇧 United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| "Patient Circuit, Heated Wire with Cable Connector" | EU MDD | Eu Md Class 2a | On Market | 1 |
| 12 / 24 V Converter (Vivo 55/65) | EU MDR | Eu Md Class 1 | On Market | 0 |
| AC Power Supply (Vivo 1-2-3) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Accessory Box Vivo 1-2-3 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Breas Patient Circuit, Single Limb with Leakage Port, Disposable | EU MDD | Eu Md Class 2a | Off Market | 1 |
| Breas Ventilator Trolley | EU MDR | Eu Md Class 1 | On Market | 0 |
| Click-In Humidifier | EU MDR | Eu Md Class 2a | On Market | 0 |
| Click-On Battery, Vivo 50/60 Series | EU MDR | Eu Md Class 1 | On Market | 0 |
| Dual Limb Insert | EU MDD | Eu Md Class 2a | On Market | 1 |
| Dual Limb Insert | EU MDD | Eu Md Class 2a | On Market | 1 |
| Dual limb adult 10pc/box | EU MDD | Eu Md Class 2a | On Market | 1 |
| Dual limb pediatric 10pc/box | EU MDD | Eu Md Class 2a | On Market | 1 |
| Effort Belt Communication Box | EU MDR | Eu Md Class 1 | On Market | 0 |
| EveryWare by Breas (v1.x.x) | EU MDR | Eu Md Class 2b | On Market | 0 |
| EveryWare by Breas (v2.x.x) | EU MDR | Eu Md Class 2b | On Market | 0 |
| EveryWare by Breas (v3.x.x) | EU MDR | Eu Md Class 2b | On Market | 0 |
| Heated Patient Circuit Type 2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Lightweight Bag (Vivo 45) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Lightweight Mobility Bag Vivo 1-2-3 | EU MDR | Eu Md Class 1 | On Market | 0 |
| MPV Arm | EU MDR | Eu Md Class 1 | On Market | 0 |
| MPV Kit (Circuit) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Mounting bracket [for Vivo 45 and Nippy w. Trolley] | EU MDR | Eu Md Class 1 | On Market | 0 |
| Mounting plate, Vivo 50 | EU MDR | Eu Md Class 1 | On Market | 0 |
| NIPPY 4 | EU MDR | Eu Md Class 2b | On Market | 0 |
| NIPPY 4+ | EU MDR | Eu Md Class 2b | On Market | 0 |
| Nitelog | EU MDD | Eu Md Class 2a | On Market | 1 |
| Nurse call NC 10kOhm ODU cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| Nurse call NC ODU cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| Nurse call NO 10kOhm ODU cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| Nurse call NO ODU cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| PC Software Vivo 1/2/3/45/45LS/Nippy 4/4+ | EU MDD | Eu Md Class 2b | On Market | 1 |
| Patient Circuit, 15mm x 1.8m | EU MDD | Eu Md Class 2a | On Market | 1 |
| Patient Circuit, 15mm x 1.8m | EU MDD | Eu Md Class 2a | On Market | 1 |
| Patient circuit arm holder | EU MDR | Eu Md Class 1 | On Market | 0 |
| PowerShell | EU MDR | Eu Md Class 1 | On Market | 0 |
| Protective Cover Vivo 55/65 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Protective cover Vivo 1-2-3 | EU MDR | Eu Md Class 1 | On Market | 0 |
| PtcCO2 cable Radiometer | EU MDR | Eu Md Class 1 | On Market | 0 |
| PtcCO2 cable Radiometer TCM5 | EU MDR | Eu Md Class 1 | On Market | 0 |
| PtcCO2 cable Sentec | EU MDR | Eu Md Class 1 | On Market | 0 |
| Remote Alarm w. ODU 10m cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| Remote Alarm w. ODU 25m cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| Remote Start/Stop (Vivo 45/Nippy 4) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Remote Start/Stop Vivo 65 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Single Limb Insert | EU MDD | Eu Md Class 2a | On Market | 1 |
| Single Patient Breathing Hose | EU MDD | Eu Md Class 2a | On Market | 1 |
| Single Patient Breathing Hose | EU MDD | Eu Md Class 2a | On Market | 1 |
| SpO2 Adapter cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| SpO2 Module | EU MDR | Eu Md Class 1 | On Market | 0 |
| Trolley IV Pole | EU MDR | Eu Md Class 1 | On Market | 0 |