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Clearo Internal Battery
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 008283Model Class I Ventilator Accessories
Identity
- Trade Name
- Clearo Internal Battery EUDAMED
- Model / Reference
- Class I Ventilator Accessories EUDAMED008283 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07321820082834 EUDAMED
- Basic UDI-DI
- 7321820139999H EUDAMED
- EMDN Code
- Z12159080 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - 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
Clearo Internal Battery by Breas Medical AB — Class I — 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 | K242438 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7321820139999H | Class I | Active |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (2)
- EUDAMED 87c932e3-c526-44ef-8d00-51c912773966 61 fields · synced Oct 5, 2026
- FDA 510(k) K242438 1 fields · synced May 18, 2026