Identity
- Trade Name
- 1350-Mobile detector holder EUDAMEDKENEX FDA UDI
- Generic Name
- X-ray film cassette holder FDA UDI
- Device Name
- X-ray film cassette holder EUDAMED1350/1 Mobile Tube Head with Detector Holder FDA UDI
- Model / Reference
- 1350/1 EUDAMEDFDA UDI
- Description
- 1350/1 Mobile Tube Head with Detector Holder FDA UDI
Identifiers
- Catalog Number
- 1350/1 FDA UDI
- Primary DI / UDI-DI
- 05055449415989 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494CH9H EUDAMED
- FDA Product Code
- IXA FDA UDI
- EMDN Code
- Z11030501 COLUMN STANDS FOR RADIOLOGICAL EQUIPMENT EUDAMED
- GMDN Term
- X-ray film cassette holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1850 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
1350-Mobile detector holder 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 | 50554494CH9H | 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 2b063dfc-f1c7-4ad9-8e1e-795393f15377 61 fields · synced Jun 19, 2026
- FDA UDI 80865cd1-8f33-43e6-80a8-07a6ed2aae14 34 fields · synced May 30, 2026