Identity
- Trade Name
- BOKE EUDAMED
- Device Name
- Attention assessment software EUDAMED
- Model / Reference
- BOKE-A001 EUDAMED001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977282760011 EUDAMED
- Basic UDI-DI
- 697728276BK24001GP EUDAMED
- EMDN Code
- Z1212012082 INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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
Boke by Boke Medical Technology (Shanghai) Co., Ltd — 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 | 697728276BK24001GP | Class I | Active |
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Manufacturer
- Manufacturer
- Boke Medical Technology (Shanghai) Co., Ltd
- EUDAMED SRN
- CN-MF-000041742
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 572dfde9-557a-4dca-b784-0af782c7f90c 61 fields · synced Aug 2, 2026