Identity
- Trade Name
- Allen EUDAMEDFDA UDI
- Generic Name
- Heel stirrup FDA UDI
- Device Name
- LP-Heel Stirrup EUDAMEDYellofins apex™ Stirrup Pair FDA UDI
- Model / Reference
- O-YFAX EUDAMED102001 FDA UDI
- Description
- Yellofins apex™ Stirrup Pair FDA UDI
Identifiers
- Catalog Number
- O-YFAX FDA UDI
- Primary DI / UDI-DI
- 00615521030629 EUDAMEDFDA UDI
- Basic UDI-DI
- 0615521GMN1020017E EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- P0999 ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER EUDAMED
- GMDN Term
- Heel stirrup 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 | 0615521GMN1020017E | 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 aed8e43a-c3f9-4aad-a396-835575aa59c7 61 fields · synced Jul 9, 2026
- FDA UDI 70212933-282b-4c1d-9161-4191dfc17ab6 35 fields · synced May 30, 2026