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Head end shield 520mmW Trendelenburg Carbon Plate
EUDAMEDFDA UDIClass I (EU MDR)
Ref 313/A2-018
Identity
- Trade Name
- Head end shield 520mmW Trendelenburg Carbon Plate EUDAMEDKENEX FDA UDI
- Generic Name
- Radiation shielding curtain FDA UDI
- Device Name
- Table mounted radiation shields EUDAMEDHead end shield 520mmW Trendelenburg Carbon Plate FDA UDI
- Model / Reference
- 313/A2-018 EUDAMEDFDA UDI
- Description
- Head end shield 520mmW Trendelenburg Carbon Plate FDA UDI
Identifiers
- Catalog Number
- 313/A2-018 FDA UDI
- Primary DI / UDI-DI
- 05055449405492 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494SHTXZ EUDAMED
- Direct Marketing DI
- 05055449405492 EUDAMED
- FDA Product Code
- KPY FDA UDI
- EMDN Code
- Z11030503 PATIENT TABLES FOR RADIOLOGICAL EQUIPMENT EUDAMED
- GMDN Term
- Radiation shielding curtain 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
Head end shield 520mmW Trendelenburg Carbon Plate 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 | 50554494SHTXZ | 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 ff8703d1-69c9-45e0-931e-04fd6efafe9f 61 fields · synced Oct 6, 2026
- FDA UDI b81f3ca0-6375-4c99-b217-ad6582e2df26 34 fields · synced May 30, 2026