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Steady Pro

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref KPHA.00Model Steady Pro

by Koelis

Identity

Trade Name
Steady Pro Arm System EUDAMED
Steady Pro FDA UDI
Generic Name
Surgical instrument assist arm system, manually-adjusted FDA UDI
Device Name
Mechanical articulated arm EUDAMED
Steady Pro (Mechanical probe holder and supports) The steady pro range is intended to reliably maintain the position of a transrectal ultrasoung probe during untra-sound-guided intervention. FDA UDI
Model / Reference
Steady Pro EUDAMED
KPHA.00 EUDAMED
KPHA.OO.EC FDA UDI
Description
Steady Pro (Mechanical probe holder and supports) The steady pro range is intended to reliably maintain the position of a transrectal ultrasoung probe during untra-sound-guided intervention. FDA UDI

Identifiers

Primary DI / UDI-DI
03665134000592 EUDAMEDFDA UDI
Basic UDI-DI
3665134SteadyPro_01S6 EUDAMED
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 EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
Not 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

Steady Pro by Koelis — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Koelis

Sources (2)

  • FDA UDI d72957ac-39b4-4060-bfb2-8f42605c4ef4 35 fields · synced Jun 19, 2026
  • EUDAMED c7058486-0367-4570-bcd3-067ae5f9fd38 61 fields · synced Jun 19, 2026