2 MHz probe, monitoring, MRI
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- 2 MHz Probe MRSafe, click&stay, orange labeling, 3 m) EUDAMED2 MHz probe, monitoring, MRI FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system probe FDA UDI
- Device Name
- 1 MHz Probes, click&stay, left side, orange labeling EUDAMED2 MHz probe (3 meter cable), click & stay, monitoring, MRI, orange marking FDA UDI
- Model / Reference
- Monitoring Probes EUDAMED6989_1 EUDAMED2 MHz_M_3_C&S_MRI_o FDA UDI
- Description
- 2 MHz probe (3 meter cable), click & stay, monitoring, MRI, orange marking FDA UDI
Identifiers
- Catalog Number
- 6989 FDA UDI
- Primary DI / UDI-DI
- 04260493310376 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260493316016VE EUDAMED
- Direct Marketing DI
- 04260493310376 EUDAMED
- 510(k) Number
- K051085 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
- GMDN Term
- Noninvasive 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
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
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
Yes
Expiration Date
No
Manufacturing Date
No
Category: Noninvasive vascular ultrasound system probe
2 MHz probe, monitoring, MRI by Compumedics Germany GmbH — Class II — MDR, 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
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 fd8f5cf4-0f0f-4015-b826-64ff8a016f85 36 fields · synced Jul 20, 2026
- EUDAMED 69189bd8-0db2-4d10-910b-c7af36568259 61 fields · synced Jul 20, 2026