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Kenex Centre Mount Shield for Valia MD21+ Arm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 354/P/88-207/LR
Identity
- Trade Name
- Kenex Centre Mount Shield for Valia MD21+ Arm EUDAMEDKenex FDA UDI
- Generic Name
- Radiation shielding panel, fixed FDA UDI
- Device Name
- Overhead suspended radiation shields (with or without lights) EUDAMED354/P/88-207/LR 85cm X 80cm center mounted shield with patient contour corner cut out and curtain. FDA UDI
- Model / Reference
- 354/P/88-207/LR EUDAMEDFDA UDI
- Description
- 354/P/88-207/LR 85cm X 80cm center mounted shield with patient contour corner cut out and curtain. FDA UDI
Identifiers
- Catalog Number
- 354/P/88-207/LR FDA UDI
- Primary DI / UDI-DI
- 05055449412285 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494SHOXP EUDAMED
- Direct Marketing DI
- 05055449412285 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
- Germany 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 Centre Mount Shield for Valia MD21+ Arm by Kenex (electro-Medical) Limited — 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 | 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 42bed769-7528-440d-9ee5-85c3098fd774 61 fields · synced Jun 18, 2026
- FDA UDI 3d91bee3-41af-4217-9762-4a4905c68353 34 fields · synced May 29, 2026