Identity
- Device Name
- BX53 EUDAMED
- Model / Reference
- N5740400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582643135531 EUDAMED
- Basic UDI-DI
- 458264313BX53BR EUDAMED
- EMDN Code
- W0202050303 OPTICAL LABORATORY MICROSCOPES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Bx53 by Evident Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 458264313BX53BR | Class A | Active |
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Manufacturer
- Manufacturer
- Evident Corporation
- EUDAMED SRN
- JP-MF-000027470
- Authorised Representative
- Evident Europe GmbH DE-AR-000025360
Sources (1)
- EUDAMED 68daeb58-ace5-4f31-8391-c646347fc3e2 61 fields · synced Jun 18, 2026