Identity
- Trade Name
- RADPAD EUDAMEDFDA UDI
- Generic Name
- Radiation shielding blanket FDA UDI
- Device Name
- Interventional Specialty Shield EUDAMEDEP Left Subclavian Shield-Red FDA UDI
- Model / Reference
- 5500 EUDAMED5400A-R EUDAMEDFDA UDI
- Description
- EP Left Subclavian Shield-Red FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852814003391 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850013127RADPADPRBW EUDAMED
- FDA Product Code
- KPY FDA UDI
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
- GMDN Term
- Radiation shielding blanket FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Market of Registration
- Netherlands 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Radpad by Worldwide Innovations & Technologies, 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 | 0850013127RADPADPRBW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Worldwide Innovations & Technologies, Inc.
- EUDAMED SRN
- US-MF-000008539
- Authorised Representative
- WIT-EAR B.V. NL-AR-000002698
Sources (2)
- EUDAMED 3579cb1b-6a4e-4801-842f-99a4f97cdbc4 61 fields · synced Jul 26, 2026
- FDA UDI af183cc3-406a-4bb7-b136-2c30481c2928 33 fields · synced May 30, 2026