Identity
- Trade Name
- Hardrock Size 4 EUDAMED
- Device Name
- Hardrock Size 1 EUDAMED
- Model / Reference
- Hardrock EUDAMED8204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056408925846 EUDAMED
- Basic UDI-DI
- 50564089SMUK010T4 EUDAMED
- EMDN Code
- Y180939 MODULAR POSTURE SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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: Assistive ergonomic chair, manually-adjusted
Hardrock Size 4 by Smirthwaite Ltd — 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 | 50564089SMUK010T4 | Class I | Active |
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Manufacturer
- Manufacturer
- Smirthwaite Limited
- EUDAMED SRN
- GB-MF-000010683
- Authorised Representative
- Evolution Healthcare Ltd XI-AR-000047925
Sources (1)
- EUDAMED 2414a605-ba07-425e-b02d-3a67cb8b7919 61 fields · synced Jul 28, 2026