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Medistim L15 Imaging Ultrasound Probe
EUDAMEDFDA UDIClass III (EU MDR)
Ref EL100015
by Medistim ASA
Identity
- Trade Name
- Medistim L15 Imaging Ultrasound Probe EUDAMEDMedistim Ultrasound Imaging Probe FDA UDI
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Device Name
- Medistim L15 Ultrasound Imaging Probe EUDAMED
- Model / Reference
- EL100015 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- EL100015 FDA UDI
- Primary DI / UDI-DI
- 07070554100931 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07070554100931 EUDAMED
- 510(k) Number
- K102595 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hydrogen Peroxide FDA UDI
Medistim L15 Imaging Ultrasound Probe by Medistim ASA — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07070554100931 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medistim ASA
- EUDAMED SRN
- NO-MF-000002741
Sources (2)
- EUDAMED 45f3122e-5295-41fd-aff1-a679ea0fba5a 61 fields · synced Jul 14, 2026
- FDA UDI 0b8f1b89-6051-4caf-9e7e-bcc1d31f586e 34 fields · synced May 30, 2026