Doppler-Box X
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Doppler BoxX EUDAMEDDoppler Box EUDAMEDDoppler-Box X FDA UDI
- Generic Name
- Invasive vascular ultrasound system FDA UDINoninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- Ultrasound Doppler Device (Doppler-Box X1) FDA UDIUltrasound Doppler Device FDA UDI
- Model / Reference
- Doppler BoxX EUDAMED7750 EUDAMED7750CN EUDAMEDDBX1 FDA UDIDBX FDA UDI
- Description
- Ultrasound Doppler Device (Doppler-Box X1) FDA UDIUltrasound Doppler Device FDA UDI
Identifiers
- Catalog Number
- 7780 FDA UDI7750 FDA UDI
- Primary DI / UDI-DI
- 04260493310055 EUDAMEDFDA UDI04260493310123 EUDAMED04260493310765 FDA UDI
- Basic UDI-DI
- 4260493317750WQ EUDAMED
- Direct Marketing DI
- 04260493310055 EUDAMED04260493310123 EUDAMED
- 510(k) Number
- K051085 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDI
- EMDN Code
- Z12040111 BLOOD FLOW METERS EUDAMED
- GMDN Term
- Invasive vascular ultrasound system FDA UDINoninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 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
Yes
Category: Invasive vascular ultrasound systemNoninvasive vascular ultrasound system, line-powered
Doppler-Box X by Compumedics Germany GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Noninvasive vascular ultrasound system, line-powered.
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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 (4)
- FDA UDI c5f3431c-3a4f-4932-a662-f241bb0a6c7a 36 fields · synced Jul 14, 2026
- FDA UDI ed3b7a05-a65e-49fb-8dd3-6f980da6b022 36 fields · synced May 30, 2026
- EUDAMED ce5fd39b-48db-4c16-b978-04b40b8dd486 61 fields · synced Jul 9, 2026
- EUDAMED 7ce6fcb3-703d-4f1e-affa-c7b69ae7f521 61 fields · synced Jul 14, 2026