Identity
- Trade Name
- SanaCardio 1000 EUDAMED
- Model / Reference
- Ergometer EUDAMED13-30-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613365500738 EUDAMED
- Basic UDI-DI
- 7613365SANABYL EUDAMED
- Direct Marketing DI
- 07613365500738 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
SanaCardio 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 5bc98e10-f532-4aeb-b342-747fd3ade9be 61 fields · synced Jun 18, 2026