Steady Pro
FDA UDIEUDAMEDClass II (US FDA UDI)
by Koelis
Identity
- Trade Name
- Steady Pro Universal clamping base EUDAMEDSteady Pro FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- Mechanical articulated arm EUDAMEDUniversal clamping base The steady pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention. FDA UDI
- Model / Reference
- KSP.UNIVCLAMP EUDAMEDFDA UDISteady Pro EUDAMED
- Description
- Universal clamping base The steady pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665134000806 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665134SteadyPro_01S6 EUDAMED
- Direct Marketing DI
- 03665134000806 EUDAMED
- 510(k) Number
- K171040 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11049080 VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical instrument assist arm system, manually-adjusted
Steady Pro by Koelis — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Koelis
Sources (2)
- FDA UDI 0804d02e-6774-4e4e-8244-9077824208c3 35 fields · synced Jun 19, 2026
- EUDAMED 8be17859-9c7b-4124-b0eb-932de9bc2d64 61 fields · synced Jun 19, 2026