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16 MHz probe, 2mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 3654Model 16 MHz Probe 2 mm
Identity
- Trade Name
- 16 MHz Probe Ø 2 mm (flexible cable, 2.5 m) EUDAMED16 MHz probe, 2mm FDA UDI
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Device Name
- 16 MHz Probe Ø 2 mm (flexible cable, 2.5 m) EUDAMED16 MHz probe, 2.0 mm diameter FDA UDI
- Model / Reference
- 16 MHz Probe 2 mm EUDAMED3654 EUDAMED16 MHz_2 FDA UDI
- Description
- 16 MHz probe, 2.0 mm diameter FDA UDI
Identifiers
- Catalog Number
- 3654 FDA UDI
- Primary DI / UDI-DI
- 04260493310468 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260493310468 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Invasive vascular ultrasound system probe
16 MHz probe, 2mm by Compumedics Germany GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Invasive vascular ultrasound system probe.
- Pencil probe — Koven Technology, Inc. · Class II
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- VRP Probe — Koven Technology, Inc. · Class II
- Pencil probe — Koven Technology, Inc. · Class II
- DOPPLEX — Huntleigh Healthcare , Ltd. · Class II
- VDP-10A — Koven Technology, Inc. · Class II
- HP Probe — Koven Technology, Inc. · Class II
- Medistim Vascular TTFM probe — Medi-Stim Asa · Class II
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
- 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
- 2 MHz probe, monitoring, MRI — Compumedics Germany GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 3271cc3c-02ad-4bbc-b94c-b291577aa8e3 36 fields · synced Jun 18, 2026
- EUDAMED e540986d-bc32-4fb5-a39d-01064de3c154 61 fields · synced Jun 18, 2026