Identity
- Trade Name
- Ganshorn.LFX EUDAMED
- Device Name
- Ganshorn.LFX EUDAMED
- Model / Reference
- 015000215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613365500073 EUDAMED
- Basic UDI-DI
- 7613365LFXGG EUDAMED
- Direct Marketing DI
- 07613365500073 EUDAMED
- EMDN Code
- Z12159092 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE 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
Ganshorn.LFX by Ganshorn Medizin Electronic Gmbh — 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 | 7613365LFXGG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ganshorn Medizin Electronic GmbH
- EUDAMED SRN
- DE-MF-000006566
Sources (1)
- EUDAMED f5a21504-4557-4cd3-ab4c-8a7c72daabba 61 fields · synced Jul 24, 2026