Identity
- Trade Name
- Rechargeable Battery Kit EUDAMED
- Device Name
- Rechargeable Battery Kit EUDAMED
- Model / Reference
- 0445 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B14004450 EUDAMED
- Basic UDI-DI
- ++B140BATTERYKITHP EUDAMED
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Battery recharger kit for recharging batteries for the MediByte. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Rechargeable Battery Kit by Braebon Medical Corporation — 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 | ++B140BATTERYKITHP | Class I | Active |
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Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-PR-000013743
Sources (1)
- EUDAMED bcadea18-6e16-4be0-933c-804c6b9adfea 61 fields · synced Oct 5, 2026