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XPAC Dual EU
EUDAMEDClass I (EU MDR)
Ref 007999Model Class I Ventilator Accessories
Identity
- Trade Name
- XPAC Dual EU EUDAMED
- Model / Reference
- Class I Ventilator Accessories EUDAMED007999 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07321820079995 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
XPAC Dual EU 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 5706b649-1b92-48ab-b828-81d09dbb7be8 61 fields · synced Jun 19, 2026