← Back to catalogue
Allen
EUDAMEDFDA UDIClass I (EU MDR)
Ref O-LPSRef A-70271Ref A-60105Ref A-93001Ref A-60103Ref A-60101Ref A-71706
Identity
- Trade Name
- Allen EUDAMEDFDA UDI
- Generic Name
- Leg procedure positioner FDA UDI
- Device Name
- LH-Leg Positioner EUDAMEDSSP-Linen or Cushion Set EUDAMEDLP-Linen or Cushion Set EUDAMEDHD-LINEN OR CUSHION SET EUDAMEDUED-Linen or Cushion Set EUDAMEDRSP-LINEN OR CUSHION SET EUDAMEDThe Prepper FDA UDI
- Model / Reference
- O-LPS EUDAMEDA-70271 EUDAMEDA-60105 EUDAMEDA-93001 EUDAMEDA-60103 EUDAMEDA-60101 EUDAMEDA-71706 EUDAMED106002 FDA UDI
- Description
- The Prepper FDA UDI
Identifiers
- Catalog Number
- O-LPS FDA UDI
- Primary DI / UDI-DI
- 00615521019730 EUDAMEDFDA UDI00615521070007 EUDAMED00615521030995 EUDAMED00615521030865 EUDAMED00615521031008 EUDAMED00615521031022 EUDAMED00615521003579 EUDAMED
- Basic UDI-DI
- 0615521GMN1060028C EUDAMED0615521GMN1030067X EUDAMED0615521GMN1020087U EUDAMED0615521GMN1080038U EUDAMED0615521GMN1010057F EUDAMED0615521GMN1070068T EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMEDL99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Leg procedure positioner 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
Yes
FDA UDI
Serial Number
No
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 | 0615521GMN1060028C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hill-Rom, Inc.
- EUDAMED SRN
- US-MF-000007306
- Authorised Representative
- Hill-Rom S.A.S. FR-AR-000003177
Sources (8)
- EUDAMED 28815dad-beed-4ad7-ba82-4d1dd52643b3 61 fields · synced Jul 24, 2026
- EUDAMED a7ba0cc5-8a66-46b4-8add-a74fc9fdc3e8 61 fields · synced May 17, 2026
- EUDAMED b778e1e6-bf31-4eca-bb85-b36eee5a8c6a 61 fields · synced May 17, 2026
- EUDAMED 7cd7a36f-88f3-46c4-a326-a66bc696be86 61 fields · synced May 17, 2026
- EUDAMED de2deb5b-4a51-4fe5-82ea-ed2e1b02de62 61 fields · synced May 17, 2026
- EUDAMED 67212f0a-ac12-4d89-b86f-cb325a5f91b4 61 fields · synced May 18, 2026
- EUDAMED 9429da09-f60f-4aa1-8c73-f8ecc04aaf24 61 fields · synced May 18, 2026
- FDA UDI 43450753-d7d6-4c16-9c5b-35b6f348c55d 35 fields · synced May 30, 2026