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BioMind Diagnostic Support Software
EUDAMEDClass IIa (EU MDR)
Ref 02C001BRO01Model HABMCMEN0001
Identity
- Device Name
- BioMind Diagnostic Support Software EUDAMED
- Model / Reference
- HABMCMEN0001 EUDAMED02C001BRO01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885017050000 EUDAMED
- Basic UDI-DI
- B-08885017050000 EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BioMind Diagnostic Support Software by Hanalytics Pte Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08885017050000 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hanalytics Pte Ltd
- EUDAMED SRN
- SG-MF-000016821
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED e66c3169-8148-41e5-90c8-2f97f5b0eca9 61 fields · synced Jul 31, 2026