Identity
- Trade Name
- Single Use Doppler Probe, NDP-10 EUDAMEDNDP Probe FDA UDI
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Device Name
- Single Use Doppler probe, NDP-10 EUDAMEDPW Bayonet style Doppler probe, 10 MHz FDA UDI
- Model / Reference
- NDP-10 EUDAMEDFDA UDI
- Description
- PW Bayonet style Doppler probe, 10 MHz FDA UDI
Identifiers
- Catalog Number
- NDP-10 FDA UDI
- Primary DI / UDI-DI
- 00894912002593 EUDAMEDFDA UDI
- Basic UDI-DI
- 00894912002593LJ EUDAMED
- 510(k) Number
- K935994 FDA UDI
- FDA Product Code
- ITX FDA UDIJAF FDA UDI
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
- GMDN Term
- Invasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1540 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Single Use Doppler Probe, NDP-10 by Koven Technology, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00894912002593LJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Koven Technology, Inc.
- EUDAMED SRN
- US-MF-000000948
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED a5919aa7-c741-4ecc-ac3c-579df452591e 61 fields · synced Jul 9, 2026
- FDA UDI 49743278-b8c5-4587-ab9d-8a7990fa6840 36 fields · synced May 30, 2026