Identity
- Trade Name
- Medistim Doppler probe EUDAMEDFDA UDI
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Device Name
- Medistim Doppler Probe EUDAMED
- Model / Reference
- PD110752 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- PD110752 FDA UDI
- Primary DI / UDI-DI
- 07070554100740 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07070554100740 EUDAMED
- 510(k) Number
- K040228 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
- GMDN Term
- Invasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Norway 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Invasive vascular ultrasound system probe
Medistim Doppler probe by Medi-Stim Asa — 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
- Probe Navigator — Z-Medical GmbH & Co. KG · Class I
- VRP Probe — Koven Technology, Inc. · Class II
- 16 MHz probe, 2mm — Compumedics Germany GmbH · Class II
- Pencil probe — Koven Technology, Inc. · Class II
- DOPPLEX — Huntleigh Healthcare , Ltd. · Class II
- 16 MHz probe, 1mm with adapter cable — Compumedics Germany GmbH · Class II
- VDP-10A — Koven Technology, Inc. · Class II
Cleared under the same submission
K040228 also covers:
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
- Medistim Interconnect Cable — Medi-Stim Asa
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
- Medi-Stim Asa
Sources (2)
- FDA UDI b5c320db-f948-4783-8225-17bdcb767a8b 34 fields · synced Jul 31, 2026
- EUDAMED f8dcb5e2-7969-4423-96c4-4eddad804364 61 fields · synced Jul 31, 2026