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Office Version Low Back - SKU - Size 5
EUDAMEDClass I (EU MDR)
Ref 12115Model Standard Seat
Identity
- Trade Name
- Office Version Low Back - SKU - Size 5 EUDAMED
- Device Name
- Standard Seat & Low Back - SKU - Size 4 EUDAMED
- Model / Reference
- Standard Seat EUDAMED12115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060517534363 EUDAMED
- Basic UDI-DI
- 50564089SMUK012T8 EUDAMED
- EMDN Code
- Y180939 MODULAR POSTURE SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Office Version Low Back - SKU - Size 5 by Smirthwaite Ltd — 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 | 50564089SMUK012T8 | 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 fdf8a7d1-560e-466a-99dd-f860cda83091 61 fields · synced Aug 1, 2026