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Summit Doppler
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref L350R-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 350R Tabletop Doppler with 2.0 MHz Fetal Probe FDA UDI
- Model / Reference
- L350R-SD2 EUDAMEDFDA UDIL150R-SD4 EUDAMED
- Description
- LifeDop 350R Tabletop Doppler with 2.0 MHz Fetal Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937002386 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD083ns43 EUDAMED
- 510(k) Number
- K090499 FDA UDI
- FDA Product Code
- MAA 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
K090499 also covers:
- MediChoice — CooperSurgical, Inc.
- MediChoice — CooperSurgical, Inc.
- MediChoice — CooperSurgical, Inc.
- MediChoice — CooperSurgical, Inc.
- MediChoice — CooperSurgical, Inc.
- MediChoice — CooperSurgical, Inc.
- Summit Doppler — CooperSurgical, Inc.
- Summit Doppler — CooperSurgical, Inc.
- Summit Doppler — CooperSurgical, Inc.
- Summit Doppler — CooperSurgical, Inc.
- Summit Doppler — CooperSurgical, Inc.
- Summit 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 |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI 5c83d950-65fb-4c93-8336-a06981568bd8 34 fields · synced Jun 19, 2026
- EUDAMED 6e98ef83-12ce-400d-bd30-eb0f55fd6ea1 61 fields · synced Jun 19, 2026