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EveryWare by Breas (v2.x.x)
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 008512Model Everyware
Identity
- Trade Name
- EveryWare by Breas (v2.x.x) EUDAMED
- Device Name
- EveryWare by Breas EUDAMED
- Model / Reference
- Everyware EUDAMED008512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07321820085125 EUDAMED
- Basic UDI-DI
- 7321820129999A EUDAMED
- EMDN Code
- Z1203019082 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - SOFTWARE ACCESSORIES 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EveryWare by Breas (v2.x.x) by Breas Medical AB — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242485 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 7321820129999A | Class IIb | Active |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (2)
- EUDAMED 95378a87-ace6-48f4-b79c-f850d6943487 61 fields · synced Jul 15, 2026
- FDA 510(k) K242485 1 fields · synced May 18, 2026