Identity
- Trade Name
- TORS EUDAMEDFDA UDI
- Generic Name
- Hard/soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- TORS - Torsional Orthopaedic Revision Surgery EUDAMEDUltrasonic system for removal of PMMA cement from human limb bone cavities in arthroplasty revision FDA UDI
- Model / Reference
- Series 1 EUDAMEDFDA UDIT1 EUDAMED
- Description
- Ultrasonic system for removal of PMMA cement from human limb bone cavities in arthroplasty revision FDA UDI
Identifiers
- Catalog Number
- 1433 FDA UDI
- Primary DI / UDI-DI
- 05060634770361 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060634770361 EUDAMED
- FDA Product Code
- JDX FDA UDI
- EMDN Code
- Z12139002 PROSTHETIC CEMENT REMOVAL EQUIPMENT EUDAMED
- GMDN Term
- Hard/soft-tissue ultrasonic surgical system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.4580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Tors by Radley Scientific Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060634770361 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Radley Scientific Ltd
- EUDAMED SRN
- GB-MF-000028143
- Authorised Representative
- endocon GmbH DE-AR-000021942
Sources (2)
- EUDAMED 753bcc7a-2c11-4b48-87bd-13a4bfb60a39 61 fields · synced Jun 6, 2026
- FDA UDI b4bd5aa7-b47c-40fd-a7e5-c8611c2971b9 35 fields · synced May 26, 2026