Identity
- Trade Name
- Kenex (Electro-Medical) Limited EUDAMEDKENEX FDA UDI
- Generic Name
- Diagnostic x-ray system chair FDA UDI
- Device Name
- Patients Imaging chair EUDAMEDHydraulic Patients Chair FDA UDI
- Model / Reference
- 1501/D EUDAMEDFDA UDI
- Description
- Hydraulic Patients Chair FDA UDI
Identifiers
- Catalog Number
- 1501/D FDA UDI
- Primary DI / UDI-DI
- 05055449416009 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494CHXVR EUDAMED
- FDA Product Code
- FRK FDA UDI
- EMDN Code
- V080299 MEDICAL CHAIRS - OTHER EUDAMED
- GMDN Term
- Diagnostic x-ray system chair FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6140 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Kenex (Electro-Medical) Limited by Kenex (electro-Medical) Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 50554494CHXVR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kenex (Electro-Medical) Limited
- EUDAMED SRN
- GB-MF-000009022
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fad5b3a9-a16d-413f-afdd-f909c5fc1800 61 fields · synced Oct 6, 2026
- FDA UDI 2398d6f8-74d7-434b-a53a-cbf5ec3b75ab 34 fields · synced May 30, 2026