Identity
- Trade Name
- Vivo 1 EUDAMEDVivo 1/2 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Vivo 1 EUDAMEDVentilator, Continuous, Non-Life-Supporting FDA UDI
- Model / Reference
- Vivo 1 EUDAMEDFDA UDI227000 EUDAMED
- Description
- Ventilator, Continuous, Non-Life-Supporting FDA UDI
Identifiers
- Catalog Number
- 227500 FDA UDI
- Primary DI / UDI-DI
- 07321822270000 EUDAMEDFDA UDI
- Basic UDI-DI
- 732182227999BJ EUDAMED
- 510(k) Number
- K240778 FDA UDI
- FDA Product Code
- MNS FDA UDINOU FDA UDI
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Vivo 1 by Breas Medical AB — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 732182227999BJ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (2)
- EUDAMED b622dcbc-32a9-4479-840e-cfee77077b87 61 fields · synced May 30, 2026
- FDA UDI b237241c-c8d9-4a6a-9543-e3d5d1342e72 36 fields · synced May 30, 2026