Identity
- Trade Name
- LuxaScope Sonus SXa „Black Edition” EUDAMED
- Device Name
- LuxaScope Sonus Stethoscope EUDAMED
- Model / Reference
- G1.211.112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260381965121 EUDAMED
- Basic UDI-DI
- 426038196StethoskopGT EUDAMED
- EMDN Code
- C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED
Classification
- Device Class
- Class I 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
LuxaScope Sonus SXa „Black Edition” by Luxamed GmbH & Co. KG — 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 | 426038196StethoskopGT | Class I | Active |
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Manufacturer
- Manufacturer
- Luxamed GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006437
Sources (1)
- EUDAMED d5567a67-dd8e-49af-9d1b-871ce7cbd7c5 61 fields · synced Jul 24, 2026