16 MHz probe, 3mm with adapter cable
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- 16 MHz Probe Ø 3 mm (flexible cable) EUDAMED16 MHz probe, 3mm with adapter cable FDA UDI
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Device Name
- 16 MHz probe Ø 3.0 mm (soft cable) with adapter cable for patient isolation FDA UDI
- Model / Reference
- Microprobes 16 MHz EUDAMED6588 EUDAMED16 MHz_3S FDA UDI
- Description
- 16 MHz probe Ø 3.0 mm (soft cable) with adapter cable for patient isolation FDA UDI
Identifiers
- Catalog Number
- 6588 FDA UDI
- Primary DI / UDI-DI
- 04260493310840 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260493310840 EUDAMED
- 510(k) Number
- K051085 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- L1699 DIAGNOSTIC INSTRUMENTS, REUSABLE- OTHER EUDAMED
- GMDN Term
- Invasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Invasive vascular ultrasound system probe
16 MHz probe, 3mm with adapter cable by Compumedics Germany GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K051085 also covers:
- 1 MHz Monitoring Adapter — Compumedics Germany GmbH
- 1 MHz probe, handheld — Compumedics Germany GmbH
- 1 MHz probe, monitoring — Compumedics Germany GmbH
- 1 MHz probe, monitoring — Compumedics Germany GmbH
- 1 MHz probe, monitoring — Compumedics Germany GmbH
- 16 MHz probe, 1mm — Compumedics Germany GmbH
- 16 MHz probe, 1mm with adapter cable — Compumedics Germany GmbH
- 16 MHz probe, 2mm — Compumedics Germany GmbH
- 2 MHz probe, handheld — Compumedics Germany GmbH
- 2 MHz probe, monitoring — Compumedics Germany GmbH
- 2 MHz probe, monitoring — Compumedics Germany GmbH
- 2 MHz probe, monitoring, MRI — Compumedics Germany GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Compumedics Germany GmbH
Sources (2)
- FDA UDI cd6df5d7-bc8b-447a-99ea-a4ca5176ab73 36 fields · synced Jun 20, 2026
- EUDAMED 69ae818d-16a7-4bf2-88dc-6160b121f90f 61 fields · synced Jun 20, 2026