Identity
- Trade Name
- DOPPLEX FDA UDI
- Generic Name
- Foetal Doppler system probe FDA UDI
- Device Name
- HIGH SENSITIVITY 3MHZ OBSTETRIC PROBE FDA UDI
- Model / Reference
- OP3XS-USA FDA UDI
- Description
- HIGH SENSITIVITY 3MHZ OBSTETRIC PROBE FDA UDI
Identifiers
- Catalog Number
- OP3XS-USA FDA UDI
- Primary DI / UDI-DI
- 05051968041272 FDA UDI
- 510(k) Number
- K183574 FDA UDI
- FDA Product Code
- HGL FDA UDI
- GMDN Term
- Foetal Doppler system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2960 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Foetal Doppler system probe
Dopplex by Huntleigh Healthcare , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183574 also covers:
- DOPPLEX — Huntleigh Healthcare , Ltd.
- DOPPLEX — Huntleigh Healthcare , Ltd.
- DOPPLEX — Huntleigh Healthcare , Ltd.
- DOPPLEX — Huntleigh Healthcare , Ltd.
- DOPPLEX — Huntleigh Healthcare , Ltd.
- DOPPLEX — Huntleigh Healthcare , Ltd.
- DOPPLEX — Huntleigh Healthcare , Ltd.
- DOPPLEX — Huntleigh Healthcare , Ltd.
- DOPPLEX — Huntleigh Healthcare , Ltd.
- DOPPLEX — Huntleigh Healthcare , Ltd.
- SONICAID — Huntleigh Healthcare , Ltd.
- SONICAID — Huntleigh Healthcare , Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Huntleigh Healthcare , Ltd.
Sources (1)
- FDA UDI fa012b56-1393-493d-9cf2-c2c9a6383407 37 fields · synced May 30, 2026