Identity
- Trade Name
- Multi-Dop® T EUDAMEDMulti-Dop T digital FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- Multi-Dop® T EUDAMEDUltrasound Doppler Device FDA UDI
- Model / Reference
- Multi-Dop® T EUDAMED8000 EUDAMEDMDT R13 FDA UDI
- Description
- Ultrasound Doppler Device FDA UDI
Identifiers
- Catalog Number
- 8000 FDA UDI
- Primary DI / UDI-DI
- 04260493310062 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260493318000VD EUDAMED
- Direct Marketing DI
- 04260493310062 EUDAMED
- 510(k) Number
- K051085 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDI
- EMDN Code
- Z12040111 BLOOD FLOW METERS EUDAMED
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1570 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
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
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
Yes
FDA UDI
Multi-Dop® T by Compumedics Germany GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4260493318000VD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Compumedics Germany GmbH
- EUDAMED SRN
- DE-MF-000005586
Sources (2)
- EUDAMED 08a7bc1c-e0b3-4bd5-b95e-930013321e34 61 fields · synced Jul 8, 2026
- FDA UDI 549d9999-7562-4330-924f-dd06aea7e181 36 fields · synced May 30, 2026