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Medistim Vascular TTFM probe
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref PV100122Ref PV100142Ref PV100061Ref PV101011Ref PV100162-20Ref PV100062-20Ref PV100141-20Ref PV100061-20Ref PV100102Ref PV100142-20Ref PV100052Ref PV100161-20Ref PV100101Ref PV100051-20Ref PV100042-20Ref PV100121-20Ref PV100082-20Ref PV100051Ref PV100062Ref PV100032-20Ref PV100042Ref PV100141Ref PV100041Ref PS100082Model PV100082Ref PV100031-20Ref PV101011-20Ref PV100121Ref PV100162
Identity
- Trade Name
- Medistim Vascular TTFM probe EUDAMEDFDA UDIMedistim Vascular TTFM porbe EUDAMED
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Device Name
- Medistim Vascular TTFM probe EUDAMED
- Model / Reference
- PV100062 EUDAMEDFDA UDIPV100082 EUDAMEDFDA UDIPV100141 EUDAMEDFDA UDIPV100061 EUDAMEDFDA UDIPV100101 EUDAMEDFDA UDIPV101011 EUDAMEDFDA UDIPV100052 EUDAMEDFDA UDIPV100041 EUDAMEDFDA UDIPV100042 EUDAMEDFDA UDIPV100051 EUDAMEDFDA UDIPV100102 EUDAMEDFDA UDIPV100121 EUDAMEDFDA UDIPV100142 EUDAMEDFDA UDIPV100162 EUDAMEDFDA UDIPV100122 EUDAMEDFDA UDIPV100162-20 EUDAMEDPV100062-20 EUDAMEDPV100141-20 EUDAMEDPV100061-20 EUDAMEDPV100142-20 EUDAMEDPV100161-20 EUDAMEDPV100051-20 EUDAMEDPV100042-20 EUDAMEDPV100121-20 EUDAMEDPV100082-20 EUDAMEDPV100032-20 EUDAMEDPS100082 EUDAMEDPV100031-20 EUDAMEDPV101011-20 EUDAMED
Identifiers
- Catalog Number
- PV100062 FDA UDIPV100082 FDA UDIPV100141 FDA UDIPV100061 FDA UDIPV100101 FDA UDIPV100052 FDA UDIPV100041 FDA UDIPV100042 FDA UDIPV100051 FDA UDIPV100102 FDA UDIPV100121 FDA UDIPV100142 FDA UDIPV100162 FDA UDIPV100122 FDA UDI
- Primary DI / UDI-DI
- 07070554100962 EUDAMEDFDA UDI07070554100986 EUDAMEDFDA UDI07070554100993 EUDAMEDFDA UDI07070554100955 EUDAMEDFDA UDI07070554101020 EUDAMEDFDA UDI07070554101112 EUDAMEDFDA UDI07070554101181 EUDAMEDFDA UDI07070554101150 EUDAMEDFDA UDI07070554101167 EUDAMEDFDA UDI07070554101174 EUDAMEDFDA UDI07070554101037 EUDAMEDFDA UDI07070554101044 EUDAMEDFDA UDI07070554101082 EUDAMEDFDA UDI07070554101075 EUDAMEDFDA UDI07070554101051 EUDAMEDFDA UDI07070554102003 EUDAMED07070554101907 EUDAMED07070554101976 EUDAMED07070554101891 EUDAMED07070554101983 EUDAMED07070554101990 EUDAMED07070554101877 EUDAMED07070554101860 EUDAMED07070554101952 EUDAMED07070554101921 EUDAMED07070554101846 EUDAMED07070554101839 EUDAMED07070554101815 EUDAMED
- Basic UDI-DI
- B-07070554101051 EUDAMEDB-07070554101082 EUDAMEDB-07070554100955 EUDAMEDB-07070554101112 EUDAMEDB-07070554102003 EUDAMEDB-07070554101907 EUDAMEDB-07070554101976 EUDAMEDB-07070554101891 EUDAMEDB-07070554101037 EUDAMEDB-07070554101983 EUDAMEDB-07070554101181 EUDAMEDB-07070554101990 EUDAMEDB-07070554101020 EUDAMEDB-07070554101877 EUDAMEDB-07070554101860 EUDAMEDB-07070554101952 EUDAMEDB-07070554101921 EUDAMEDB-07070554101174 EUDAMEDB-07070554100962 EUDAMEDB-07070554101846 EUDAMEDB-07070554101167 EUDAMEDB-07070554100993 EUDAMEDB-07070554101150 EUDAMEDB-07070554100986 EUDAMEDB-07070554101839 EUDAMEDB-07070554101815 EUDAMEDB-07070554101044 EUDAMEDB-07070554101075 EUDAMED
- 510(k) Number
- K992305 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 EUDAMEDSpain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA 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 Vascular TTFM probe by Medi-Stim Asa — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Invasive vascular ultrasound system probe.
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- Pencil probe — Koven Technology, Inc. · Class II
- DOPPLEX — Huntleigh Healthcare , Ltd. · Class II
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- VDP-10A — Koven Technology, Inc. · Class II
Cleared under the same submission
K992305 also covers:
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — 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 (43)
- FDA UDI 3eb64b6a-d364-42f0-9b9a-44af64178c80 34 fields · synced Aug 3, 2026
- FDA UDI fa076600-67e0-407e-be6b-89e442c42f2d 34 fields · synced May 25, 2026
- FDA UDI 42568c06-d844-4718-b34a-16f5122c8afb 34 fields · synced May 25, 2026
- FDA UDI b458dfb8-db38-4330-a07e-0d3ef4904ea6 34 fields · synced May 25, 2026
- FDA UDI a2b1db16-7f70-4ee6-9663-01f988675d37 34 fields · synced May 29, 2026
- FDA UDI 5af674a3-b527-4297-b73d-2e892506fe44 33 fields · synced May 29, 2026
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- FDA UDI cf2e305e-e6f1-464b-9b7d-374c78c12940 34 fields · synced May 30, 2026
- FDA UDI 94936467-3db7-41cb-b28e-c55950282ebb 34 fields · synced May 30, 2026
- FDA UDI 41aabe87-ceb2-4a19-a8d0-dcc8e0bb00bb 34 fields · synced May 30, 2026
- FDA UDI e84b1f4a-1dee-4333-97d0-eaf2ec6512e3 34 fields · synced May 30, 2026
- FDA UDI a09a315e-3e0b-4f0d-94e1-c802ad34a8d6 34 fields · synced May 30, 2026
- FDA UDI e15ecbe5-b33d-4a65-b953-2bb5bd753fa8 34 fields · synced May 30, 2026
- FDA UDI 19a3af07-48cd-4e26-b4d0-9f2078cb1f47 34 fields · synced May 30, 2026
- FDA UDI a259944b-d73f-45b3-9655-b439ff327f81 34 fields · synced May 30, 2026
- EUDAMED 902b2927-7087-4f95-a592-a81743d21e40 61 fields · synced Jul 8, 2026
- EUDAMED ee4294f9-6041-461d-b650-650b9fc7e46c 61 fields · synced Jul 8, 2026
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- EUDAMED 4295ee30-0467-4afa-89ee-8e811ceedf8a 61 fields · synced Jul 9, 2026
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- EUDAMED d4fa5f44-fd47-4304-851f-e57db3ae0eb7 61 fields · synced Jul 12, 2026
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- EUDAMED ece214b3-7a73-4993-8bb3-68500847f2e2 61 fields · synced Jul 21, 2026
- EUDAMED abb0b81f-d4dc-438a-bd33-0c982728ab9a 61 fields · synced Jul 23, 2026
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- EUDAMED 29b2cac8-fced-4aea-83b0-7bb651109ffa 61 fields · synced Jul 23, 2026
- EUDAMED b9078257-2856-4086-9db2-f3a07289328a 61 fields · synced Jul 25, 2026
- EUDAMED 80bde340-0a0b-4f8e-afa3-2809d9571cda 61 fields · synced Jul 26, 2026
- EUDAMED 5b03f5b0-978f-402c-bdd3-5db0e71b597c 61 fields · synced Jul 26, 2026
- EUDAMED 0d23df54-4f78-483c-afb8-d844f3ee866e 61 fields · synced Jul 28, 2026
- EUDAMED 34ffbe61-a02d-4d7b-8dc4-0807da15242d 61 fields · synced Jul 31, 2026
- EUDAMED ac8d2c62-3771-4446-848c-4b796e978ed1 61 fields · synced Aug 3, 2026