Identity
- Trade Name
- Summit Doppler™ LifeDop® EUDAMEDSummit Doppler FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system probe FDA UDI
- Device Name
- LifeDop™ (Vascular Dopplers) Noninvasive Vascular Ultrasound System, Battery-Powered EUDAMEDLifeDop 8.0 MHz Vascular Probe FDA UDI
- Model / Reference
- SD8 EUDAMEDFDA UDIL150R-SD4 EUDAMED
- Description
- LifeDop 8.0 MHz Vascular Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937002003 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD083ns43 EUDAMED
- 510(k) Number
- K024197 FDA UDI
- FDA Product Code
- HEP FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Noninvasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2660 FDA UDI
- Market of Registration
- Netherlands 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
No
Category: Noninvasive vascular ultrasound system probe
Summit Doppler by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K024197 also covers:
- 5.0 MHz Deep Vascular Probe — CooperSurgical, Inc.
- 8.0 MHz Superficial Vascular Probe — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
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
- CooperSurgical, Inc.
Sources (2)
- FDA UDI 63bc3962-34c6-4b30-8183-39079b307145 34 fields · synced Jul 15, 2026
- EUDAMED 477ac22b-cdcc-45f5-b726-c56e513640ed 61 fields · synced Jul 15, 2026