Identity
- Trade Name
- Pure Siro EUDAMED
- Device Name
- Pure shower stools EUDAMED
- Model / Reference
- 1654343 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04028698135695 EUDAMED
- Basic UDI-DI
- 4028698PureStoolZR EUDAMED
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER 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
Category: Hydrotherapy bath/tank
Pure Siro by Invacare GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 4028698PureStoolZR | Class I | Active |
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Manufacturer
- Manufacturer
- Invacare GmbH
- EUDAMED SRN
- DE-MF-000006985
Sources (1)
- EUDAMED 51869e2c-52f7-4fa5-9d83-c2eb3b48cf89 61 fields · synced Jul 25, 2026