← Back to catalogue
Summit Doppler
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref L250R-SD2Model L150R-SD4
Identity
- Trade Name
- Summit Doppler™ LifeDop® EUDAMEDSummit Doppler FDA UDI
- Generic Name
- Foetal Doppler system FDA UDI
- Device Name
- LifeDop™ (Vascular Dopplers) Noninvasive Vascular Ultrasound System, Battery-Powered EUDAMEDLifeDop 250R Professional with 2.0 MHz Fetal Probe FDA UDI
- Model / Reference
- L250R-SD2 EUDAMEDFDA UDIL150R-SD4 EUDAMED
- Description
- LifeDop 250R Professional with 2.0 MHz Fetal Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937002201 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD083ns43 EUDAMED
- 510(k) Number
- K024197 FDA UDI
- FDA Product Code
- KNG FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Foetal Doppler system 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
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
No
FDA UDI
Category: Foetal Doppler system
Summit Doppler by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Foetal Doppler system.
- CONTEC — Contec Medical Systems Co., Ltd. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Hi-dop — Bistos Co., Ltd. · Class II
- CONTEC — Contec Medical Systems Co., Ltd. · Class II
- VCOMIN Fetal Doppler — Vcomin Technlogy Limited · Class II
- DigiDop — Newman Medical · Class II
- DigiDop — Newman Medical · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
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
European Union Unknown
MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI 75a397e9-744e-460b-b0d8-0a6efc0acb1a 34 fields · synced Jun 19, 2026
- EUDAMED 8b0a3b7b-7dc0-494f-82f6-09233592e892 61 fields · synced Jun 19, 2026