Identity
- Trade Name
- SanaComfort 1000 EUDAMED
- Model / Reference
- Ergometer EUDAMED14-30-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613365500776 EUDAMED
- Basic UDI-DI
- 7613365SANABYL EUDAMED
- EMDN Code
- Z129003 CYCLES FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SanaComfort 1000 by Ganshorn Medizin Electronic Gmbh — 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 | 7613365SANABYL | Class I | Active |
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Manufacturer
- Manufacturer
- Ganshorn Medizin Electronic GmbH
- EUDAMED SRN
- DE-MF-000006566
Sources (1)
- EUDAMED 8333a3fc-a424-4ad1-8064-afb6c4bc6529 61 fields · synced Jul 14, 2026