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Z1 Power Shell
EUDAMEDClass I (EU MDR)
Ref 005767Model Class I Ventilator Accessories
Identity
- Trade Name
- Z1 Power Shell EUDAMED
- Model / Reference
- Class I Ventilator Accessories EUDAMED005767 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07321820057672 EUDAMED
- Basic UDI-DI
- 7321820139999H EUDAMED
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Z1 Power Shell by Breas Medical AB — Class I — 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 | 7321820139999H | Class I | Active |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (1)
- EUDAMED c9d5b87e-2cea-47bf-adbf-3052af51d727 61 fields · synced Oct 6, 2026