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Benecura 3.4
EUDAMEDClass IIa (EU MDR)
Ref 28Model Patienten-App
by Helmedica AG
Identity
- Trade Name
- Benecura 3.4 EUDAMED
- Device Name
- Benecura EUDAMED
- Model / Reference
- Patienten-App EUDAMED28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649990987118 EUDAMED
- Basic UDI-DI
- 7649990987BenecuraDJ EUDAMED
- Direct Marketing DI
- 07649990987118 EUDAMED
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Benecura 3.4 by Helmedica AG — Class IIa — 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 | 7649990987BenecuraDJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Helmedica AG
- EUDAMED SRN
- CH-MF-000040546
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (1)
- EUDAMED 4e9032f8-1b52-438d-9d9b-930f294066f1 61 fields · synced Jun 20, 2026