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312/DS/3.138 Top Shield 40 x 27.5cm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 312/DS/3.138
Identity
- Trade Name
- 312/DS/3.138 Top Shield 40 x 27.5cm EUDAMEDKENEX FDA UDI
- Generic Name
- Radiation shielding curtain FDA UDI
- Device Name
- Table mounted radiation shields EUDAMED312/DS/3.138 Top Shield 40 x 27.5cm FDA UDI
- Model / Reference
- 312/DS/3.138 EUDAMEDFDA UDI
- Description
- 312/DS/3.138 Top Shield 40 x 27.5cm FDA UDI
Identifiers
- Catalog Number
- 312/DS/3.138 FDA UDI
- Primary DI / UDI-DI
- 05055449402514 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494SHTXZ EUDAMED
- Direct Marketing DI
- 05055449402514 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
312/DS/3.138 Top Shield 40 x 27.5cm 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 | 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 3fdd3bc2-f174-4675-ae7a-743918d9bd40 61 fields · synced Jun 19, 2026
- FDA UDI 9a4b2e44-7795-4ed1-bb4d-845f64186697 34 fields · synced May 30, 2026