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Steady Pro
EUDAMEDFDA UDIClass I (EU MDR)
Ref KSP.ARMModel Steady ProRef KSP.Arm
by Koelis
Identity
- Trade Name
- Steady Pro EUDAMEDFDA UDISteady Pro Arm system EUDAMED
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- Mechanical articulated arm EUDAMEDSteady Pro Probe Holding Arm with I and U extension and rail 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
- Steady Pro EUDAMEDKSP.ARM EUDAMEDFDA UDI
- Description
- Steady Pro Probe Holding Arm with I and U extension and rail 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
- 03665134000738 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665134SteadyPro_01S6 EUDAMED
- Direct Marketing DI
- 03665134000738 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
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
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
Yes
FDA UDI
Steady Pro by Koelis — 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 | 3665134SteadyPro_01S6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Koelis
- EUDAMED SRN
- FR-MF-000000830
Sources (3)
- EUDAMED 617001cf-e0e0-4647-896f-73b6f85ca4c0 61 fields · synced Jul 18, 2026
- FDA UDI 1b3a00f6-4942-483e-869d-c09ba536db1e 35 fields · synced May 30, 2026
- EUDAMED 7a881e01-ce81-4924-8d69-b0e83f89203d 61 fields · synced Jul 18, 2026