← Back to catalogue
Instrument Kit: S2 Platform E/ F/ G
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1737
by Integrum AB
Identity
- Trade Name
- Instrument Kit: S2 Platform E/ F/ G EUDAMEDOPRA Implant System FDA UDI
- Generic Name
- Internal-external leg prosthesis osseointegration bar FDA UDI
- Device Name
- OPRA Implant System Instruments - OPRA Instrument Kits EUDAMEDOPRA S2 Instrument Kit FDA UDI
- Model / Reference
- 1737 EUDAMEDFDA UDI
- Description
- OPRA S2 Instrument Kit FDA UDI
Identifiers
- Catalog Number
- 1737 FDA UDI
- Primary DI / UDI-DI
- 07340152101235 EUDAMEDFDA UDI
- Basic UDI-DI
- 73401521RUinstrumentkit4A EUDAMED
- Direct Marketing DI
- 07340152101235 EUDAMED
- PMA Number
- H080004 FDA UDI
- FDA Product Code
- PJY FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - 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
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Instrument Kit: S2 Platform E/ F/ G 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 | 73401521RUinstrumentkit4A | 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
- Integrum AB
- EUDAMED SRN
- SE-MF-000026900
Sources (2)
- EUDAMED f5fe9a21-4ac6-426d-8a0d-8ef50116051c 61 fields · synced Jul 9, 2026
- FDA UDI 5673e53c-4e1e-4422-9e97-8d7a079fd33d 36 fields · synced May 30, 2026