Identity
- Trade Name
- Steradian Shield EUDAMEDFDA UDI
- Generic Name
- Patient radiation shielding pad/drape, single-use FDA UDI
- Device Name
- Steradian Shield EUDAMEDRadiation Protection Shield FDA UDI
- Model / Reference
- SS0200 EUDAMEDFDA UDI
- Description
- Radiation Protection Shield FDA UDI
Identifiers
- Catalog Number
- SS0200 FDA UDI
- Primary DI / UDI-DI
- 00853714008080 EUDAMEDFDA UDI
- Basic UDI-DI
- 0853714008SS0000W5 EUDAMED
- FDA Product Code
- KPY FDA UDIPUI FDA UDI
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
- GMDN Term
- Patient radiation shielding pad/drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI878.4370 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Steradian Shield by Radux Devices, Inc — 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 | 0853714008SS0000W5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Radux Devices, Inc
- EUDAMED SRN
- US-MF-000034745
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 9349fe50-47a0-4710-b11e-d4580f994a48 61 fields · synced Jun 18, 2026
- FDA UDI f503a62b-3ae9-4125-b6ef-3f290b036db9 35 fields · synced May 30, 2026