Identity
- Trade Name
- Soleo Galva EUDAMED
- Model / Reference
- Soleoline EUDAMED5331 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04053915985432 EUDAMED
- Basic UDI-DI
- 4053815D5301D5 EUDAMED
- Direct Marketing DI
- 04053915985432 EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa 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
Soleo Galva by Zimmer MedizinSysteme 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 | 4053815D5301D5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zimmer MedizinSysteme GmbH
- EUDAMED SRN
- DE-MF-000006141
Sources (1)
- EUDAMED ee839e62-95f3-4a8e-8532-1f6fc969fb31 61 fields · synced Jun 18, 2026