Identity
- Trade Name
- Vivo 55 EUDAMED
- Device Name
- Vivo 55 EUDAMED
- Model / Reference
- Vivo 55 EUDAMED221000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07321822210006 EUDAMED
- Basic UDI-DI
- 732182221999A8 EUDAMED
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Vivo 55 by Breas Medical AB — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 732182221999A8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (1)
- EUDAMED 49306bb1-dd2c-4ddc-b51d-c88abd79fbde 61 fields · synced Jun 19, 2026