Identity
- Trade Name
- 100/428 Skirt Hook (pair) EUDAMEDKENEX FDA UDI
- Generic Name
- Radiation shielding apron rack FDA UDI
- Device Name
- Storage Racks for the radiation shields EUDAMED100/428 Skirt Hook (pair) FDA UDI
- Model / Reference
- 100/428 EUDAMEDFDA UDI
- Description
- 100/428 Skirt Hook (pair) FDA UDI
Identifiers
- Catalog Number
- 100/428 FDA UDI
- Primary DI / UDI-DI
- 05055449414067 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494AR9X EUDAMED
- Direct Marketing DI
- 05055449414067 EUDAMED
- FDA Product Code
- KPY FDA UDI
- EMDN Code
- T030499 RADIOTHERAPY PROTECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Radiation shielding apron rack 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
100/428 Skirt Hook (pair) 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 | 50554494AR9X | 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 11c1d5df-f5c0-468c-a58c-c87414614a16 61 fields · synced Jun 20, 2026
- FDA UDI 5946a01c-5207-45b3-bc53-32c21951b912 34 fields · synced May 29, 2026