Identity
- Trade Name
- Shadow Multi-Purpose Shield EUDAMEDShadow Radiation Shield FDA UDI
- Generic Name
- Radiation shielding curtain FDA UDI
- Device Name
- M1128 RADIATION SHIELD RIGHT TABLE VERSION EUDAMEDAll purpose radiation shield FDA UDI
- Model / Reference
- L148-MPS EUDAMEDFDA UDI
- Description
- All purpose radiation shield FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010101216 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600020901RadshieldX5 EUDAMED
- FDA Product Code
- KPY FDA UDI
- EMDN Code
- T030499 RADIOTHERAPY PROTECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Radiation shielding curtain FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Market of Registration
- 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
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Shadow Multi-Purpose Shield by Rampart Ic, Llc — 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 | 08600020901RadshieldX5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rampart Ic, Llc
- EUDAMED SRN
- US-MF-000007613
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (2)
- EUDAMED 0ba86cfa-6b88-4828-9783-3092af8f0220 61 fields · synced Jul 9, 2026
- FDA UDI 31d5716a-85cd-4f46-8204-19d2dd111f6d 33 fields · synced May 30, 2026