Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fe…
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Pocket Fetal Doppler EUDAMEDCONTEC FDA UDI
- Generic Name
- Foetal Doppler system FDA UDI
- Device Name
- Pocket Fetal Doppler EUDAMEDFDA UDI
- Model / Reference
- CONTEC10C EUDAMEDFDA UDICONTEC10CL EUDAMEDFDA UDICONTEC10C, CONTEC10CL EUDAMED
- Description
- Pocket Fetal Doppler FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040105404 EUDAMEDFDA UDI06945040105411 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450401CONTEC10CA7 EUDAMED
- Direct Marketing DI
- 06945040105411 EUDAMED06945040105404 EUDAMED
- FDA Product Code
- KNG FDA 510(k)FDA UDI
- EMDN Code
- Z12080103 FOETAL HEARTBEAT DETECTORS EUDAMED
- GMDN Term
- Foetal Doppler system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 884.2660 FDA 510(k)
- Regulation Number
- 884.2660 FDA 510(k)FDA UDI
- Market of Registration
- Hungary EUDAMEDItaly EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
Yes
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
The Pocket Fetal Doppler (CONTEC 10D, 10E, 10F) is a handheld ultrasonic fetal heart rate monitor designed for non-invasive detection of fetal heart sounds. It employs pulsed-wave Doppler technology to transmit and receive audio signals, enabling real-time assessment of fetal heart rate via an LED display that also indicates heartbeats and signal strength.
These devices are intended for use in obstetric settings by healthcare professionals to monitor fetal heart rate during pregnancy. Supplied as single-use or reusable (as specified by the manufacturer), they require no sterilisation and are classified as Class II medical devices under FDA regulations. Each model (10D, 10E, 10F) is authorised via FDA 510(k) clearance and MDR compliance, with registration numbers and FEI codes listed in the regulatory database.
Frequently asked questions
What is the primary purpose of the Pocket Fetal Doppler (CONTEC 10D/E/F) in clinical settings?
The Pocket Fetal Doppler (CONTEC 10D, 10E, 10F) is designed for non-invasive monitoring of fetal heart rate during pregnancy. It uses pulsed-wave Doppler technology to transmit and receive audio signals, allowing healthcare professionals to assess fetal heartbeats in real-time via an LED display that also shows signal strength. This handheld device is specifically intended for obstetric use to support prenatal care.
Are these devices single-use or reusable, and do they require sterilization?
The Pocket Fetal Doppler models (10D, 10E, 10F) can be supplied as either single-use or reusable, depending on the manufacturer’s specifications for each model. Importantly, the device description explicitly states that no sterilization is required for use, making it convenient for clinical settings where reprocessing may be impractical.
How do I determine which model (10D, 10E, or 10F) is right for my practice?
While the provided data does not specify functional differences between the 10D, 10E, and 10F models, they are all FDA 510(k)-cleared and MDR-compliant for obstetric fetal heart monitoring. The choice may depend on factors like intended use frequency, whether single-use or reusable is preferred, or compatibility with your practice’s workflow. For precise model selection, consult the manufacturer’s documentation or contact Contec Medical Systems for model-specific details.
What regulatory pathways have these devices undergone, and how does that affect their use?
The Pocket Fetal Doppler models (10D/E/F) are FDA 510(k)-cleared under the Traditional pathway, classified as Class II devices for obstetrics/gynecology use. They are also MDR-compliant, meaning they meet European Union regulatory standards. This clearance confirms their safety and effectiveness for non-invasive fetal heart rate monitoring in obstetric settings, but it does not imply any specific clinical indication beyond what’s stated in the description.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CONTEC10D Pocket Fetal Doppler-CONTEC MEDICAL SYSTEMS CO.,LTD, Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E ..., CONTEC10E Pocket Fetal Doppler-CONTEC MEDICAL SYSTEMS CO.,LTD, Fetal Doppler-CONTEC Medical Systems Co., Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232893 | Class II | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- FDA Applicant
- Contec Medical Systems Co.,Ltd
Sources (5)
- FDA 510(k) K232893 24 fields · synced Sep 18, 2026
- FDA UDI b46db247-89df-473d-afc9-64c0f5def517 34 fields · synced May 29, 2026
- FDA UDI 8c488bf6-49cc-4556-9270-dca41dcb64bd 34 fields · synced May 30, 2026
- EUDAMED a78f1ba3-bd4e-4908-8302-951c3f627e50 61 fields · synced Jul 14, 2026
- EUDAMED 3612bfb3-1885-42b8-8a7b-f99d7911be17 61 fields · synced Jul 20, 2026