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Soft Tissue Support Pylon
EUDAMEDFDA UDIClass I (EU MDR)
Ref IBK0041
by Integrum AB
Identity
- Trade Name
- Soft Tissue Support Pylon EUDAMEDOPRA Implant System FDA UDI
- Generic Name
- Internal-external leg prosthesis osseointegration bar FDA UDI
- Device Name
- OPRA Implant System - Accessories EUDAMEDSoft Tissue Support Pylon FDA UDI
- Model / Reference
- IBK0041 EUDAMEDFDA UDI
- Description
- Soft Tissue Support Pylon FDA UDI
Identifiers
- Catalog Number
- IBK0041 FDA UDI
- Primary DI / UDI-DI
- 07340152101341 EUDAMEDFDA UDI
- Basic UDI-DI
- 73401521accessoriesopra73 EUDAMED
- PMA Number
- H080004 FDA UDI
- FDA Product Code
- PJY FDA UDI
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
- GMDN Term
- Internal-external leg prosthesis osseointegration bar FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Soft Tissue Support Pylon by Integrum AB — 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 | 73401521accessoriesopra73 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Integrum AB
- EUDAMED SRN
- SE-MF-000026900
Sources (2)
- EUDAMED 3c6b0941-8c98-4b19-94a9-873dcd07b647 61 fields · synced Jun 18, 2026
- FDA UDI c477df88-d88f-4f75-a74b-ab193759a602 35 fields · synced May 30, 2026