Identity
- Trade Name
- Accord BX53 EUDAMED
- Device Name
- Accord EUDAMED
- Model / Reference
- Duet EUDAMEDSAC5200C5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290107655385 EUDAMED
- Basic UDI-DI
- 729010765DUETDJ EUDAMED
- Direct Marketing DI
- 07290107655385 EUDAMED
- EMDN Code
- W0202050304 DIGITAL 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
Accord BX53 by BioView Ltd. — 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 | 729010765DUETDJ | Class A | Active |
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Manufacturer
- Manufacturer
- BioView Ltd.
- EUDAMED SRN
- IL-MF-000036039
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 069141e1-aeff-46bb-ad52-efb134ca7e03 61 fields · synced Jul 8, 2026