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326/05 - Height adjustable Over table Shield
EUDAMEDFDA UDIClass I (EU MDR)
Ref 326/05
Identity
- Trade Name
- 326/05 - Height adjustable Over table Shield EUDAMEDKENEX FDA UDI
- Generic Name
- Radiation shielding panel, portable/mobile FDA UDI
- Device Name
- Mobile and portable radiation shield panels EUDAMEDPanaramic height adjustable over-table shield FDA UDI
- Model / Reference
- 326/05 EUDAMEDFDA UDI
- Description
- Panaramic height adjustable over-table shield FDA UDI
Identifiers
- Catalog Number
- 326/05 FDA UDI
- Primary DI / UDI-DI
- 05055449401838 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494SHMXK EUDAMED
- FDA Product Code
- IWX FDA UDI
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
- GMDN Term
- Radiation shielding panel, portable/mobile 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
326/05 - Height adjustable Over table Shield 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 | 50554494SHMXK | 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 6154d9b7-b2ad-4fd3-b25b-f7b4491d22d7 61 fields · synced Oct 5, 2026
- FDA UDI c547b764-db90-454a-bd01-620459874f59 34 fields · synced May 30, 2026