Identity
- Trade Name
- Allen EUDAMEDFDA UDI
- Generic Name
- Multi-purpose diagnostic imaging table FDA UDI
- Device Name
- VI-Imaging table Accessories EUDAMEDS18061MH: Head Widener GE Part Number: 5402054 007 FDA UDI
- Model / Reference
- GE5402054 EUDAMED112005 FDA UDI
- Description
- S18061MH: Head Widener GE Part Number: 5402054 007 FDA UDI
Identifiers
- Catalog Number
- GE5402054 FDA UDI
- Primary DI / UDI-DI
- 00615521015411 EUDAMEDFDA UDI
- Basic UDI-DI
- 0615521GMN1120057Z EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- Z11030503 PATIENT TABLES FOR RADIOLOGICAL EQUIPMENT EUDAMED
- GMDN Term
- Multi-purpose diagnostic imaging table FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- France 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
Yes
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
Yes
FDA UDI
Allen by Hill-Rom, 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 | 0615521GMN1120057Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
- EUDAMED SRN
- US-MF-000007306
- Authorised Representative
- Hill-Rom S.A.S. FR-AR-000003177
Sources (2)
- EUDAMED bb68dd42-627d-444f-85a7-e3c966cc54f0 61 fields · synced May 30, 2026
- FDA UDI 9cc1b68f-a9fc-431b-b1fa-03049a674fbc 35 fields · synced May 30, 2026