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PC Software Vivo 1/2/3/45/45LS/Nippy 4/4+
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 007067Model PC Software
Identity
- Trade Name
- PC Software Vivo 1/2/3/45/45LS/Nippy 4/4+ EUDAMEDVivo 45 LS FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- Vivo 1/2/3/45/45LS/Nippy 4/4+ PC Software EUDAMEDPC Software Vivo 45 LS FDA UDI
- Model / Reference
- PC Software EUDAMED007067 EUDAMEDFDA UDI
- Description
- PC Software Vivo 45 LS FDA UDI
Identifiers
- Catalog Number
- 007067 FDA UDI
- Primary DI / UDI-DI
- 07321820070671 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07321820070671 EUDAMED
- 510(k) Number
- K193586 FDA UDI
- FDA Product Code
- CBK FDA UDINOU FDA UDI
- EMDN Code
- Z1203019082 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Medical equipment clinical data interfacing software 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PC Software Vivo 1/2/3/45/45LS/Nippy 4/4+ by Breas Medical AB — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07321820070671 | 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 3321439d-e427-4923-9bb6-d232e0ed1fcd 61 fields · synced Jun 19, 2026
- FDA UDI dc6fc876-50cc-48c7-91dc-d61c4f00b9da 36 fields · synced May 30, 2026