Identity
- Trade Name
- 1305-Mobile cassette holder EUDAMEDKENEX FDA UDI
- Generic Name
- X-ray film cassette holder FDA UDI
- Device Name
- X-ray film cassette holder EUDAMED1305/3/1 Mobile Cassette Holder FDA UDI
- Model / Reference
- 1305/3/1 EUDAMEDFDA UDI
- Description
- 1305/3/1 Mobile Cassette Holder FDA UDI
Identifiers
- Catalog Number
- 1305/3/1 FDA UDI
- Primary DI / UDI-DI
- 05055449413992 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
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
1305-Mobile cassette 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 e5a067e8-d164-411f-9035-ca4e9a702dd7 61 fields · synced Oct 5, 2026
- FDA UDI 63cc2c48-87ca-4aae-9e6a-095f22f4f301 34 fields · synced May 30, 2026