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Steady Pro support for Full-3D endocavity end-fire probe
EUDAMEDClass I (EU MDR)
Ref KPHA.EC.2Model Steady Pro
by Koelis
Identity
- Trade Name
- Steady Pro support for Full-3D endocavity end-fire probe EUDAMED
- Device Name
- Mechanical articulated arm EUDAMED
- Model / Reference
- Steady Pro EUDAMEDKPHA.EC.2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03665134000424 EUDAMED
- Basic UDI-DI
- 3665134SteadyPro_01S6 EUDAMED
- EMDN Code
- Z11049080 VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Steady Pro support for Full-3D endocavity end-fire probe by Koelis — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3665134SteadyPro_01S6 | Class I | Active |
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Manufacturer
- Manufacturer
- Koelis
- EUDAMED SRN
- FR-MF-000000830
Sources (1)
- EUDAMED 598602d3-5286-4ea8-b5db-26c8e3aad2d7 61 fields · synced Jul 9, 2026