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QA4 Mobile Surgery System with Powered Functions - includes Pressure Care Mattr…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 21300
Identity
- Trade Name
- QA4 Mobile Surgery System with Powered Functions - includes Pressure Care Mattress EUDAMEDQA4 Mobile Surgery System FDA UDI
- Generic Name
- Universal operating table, electromechanical FDA UDI
- Device Name
- QA4 Surgery Trolley System EUDAMED
- Model / Reference
- 21300 EUDAMEDQA4 Mobile Surgery Platfrom FDA UDI
Identifiers
- Catalog Number
- 21300 FDA UDI
- Primary DI / UDI-DI
- 05051995000020 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051995QA4SYSTEML8 EUDAMED
- FDA Product Code
- GDC FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Universal operating table, electromechanical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
QA4 Mobile Surgery System with Powered Functions - includes Pressure Care Mattr… by Anetic Aid Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5051995QA4SYSTEML8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Anetic Aid Ltd
- EUDAMED SRN
- GB-MF-000011932
- Authorised Representative
- EU-UK Authorised Representative Ltd XI-AR-000010192
Sources (2)
- EUDAMED aef7ad68-7602-4240-b00c-4f53f28d3825 61 fields · synced Jul 28, 2026
- FDA UDI 0858d923-03fa-440b-841e-e18493f30720 33 fields · synced May 29, 2026