Identity
- Trade Name
- 351-Upperbody radiation shield EUDAMEDKENEX FDA UDI
- Generic Name
- Radiation shielding panel, fixed FDA UDI
- Device Name
- Overhead suspended radiation shields (with or without lights) EUDAMED60h x 80w Shield with cut-out& Ceiling Column FDA UDI
- Model / Reference
- 351/P/68-001 EUDAMEDFDA UDI
- Description
- 60h x 80w Shield with cut-out& Ceiling Column FDA UDI
Identifiers
- Catalog Number
- 351/P/68-001 FDA UDI
- Primary DI / UDI-DI
- 05055449400176 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494SHOXP EUDAMED
- FDA Product Code
- EAK FDA UDI
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
- GMDN Term
- Radiation shielding panel, fixed FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 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
351-Upperbody radiation shield 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 | 50554494SHOXP | 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 90c33588-dbef-4624-b499-768a914967d6 61 fields · synced Jun 18, 2026
- FDA UDI 0db2a466-d167-489c-af80-1223ceaabf88 34 fields · synced May 30, 2026