Identity
- Trade Name
- Shield System EUDAMEDFDA UDI
- Generic Name
- Radiation shielding panel, fixed FDA UDI
- Device Name
- Shield System EUDAMED
- Model / Reference
- TPL0001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018378045 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290018378TPLBD EUDAMED
- Direct Marketing DI
- 07290018378045 EUDAMED
- 510(k) Number
- K212159 FDA UDI
- FDA Product Code
- OWB FDA UDI
- EMDN Code
- T030599 HEALTH SERVICE PREMISES PROTECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Radiation shielding panel, fixed FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Poland 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Shield System by Radiaction Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222625 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K212159 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7290018378TPLBD | Class I | Active |
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Manufacturer
- Manufacturer
- Radiaction Ltd.
- EUDAMED SRN
- IL-MF-000023275
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 3dcf2318-d5d7-4229-9cb9-bb316df28be4 61 fields · synced Jul 9, 2026
- FDA UDI ed9664c6-6f17-4f81-abbb-3535587c1a61 34 fields · synced May 26, 2026
- FDA 510(k) K222625 1 fields · synced May 18, 2026