Identity
- Trade Name
- DOPPLEX FDA UDI
- Generic Name
- Foetal/maternal prenatal monitor FDA UDI
- Device Name
- FM830-SL ENCORE COMPLETE SYSTEM FDA UDI
- Model / Reference
- FM830-SL-ENCORE FDA UDI
- Description
- FM830-SL ENCORE COMPLETE SYSTEM FDA UDI
Identifiers
- Catalog Number
- ENCOR-FM830S-UN FDA UDI
- Primary DI / UDI-DI
- 05051968031792 FDA UDI
- 510(k) Number
- K090285 FDA UDI
- FDA Product Code
- HGM FDA UDI
- GMDN Term
- Foetal/maternal prenatal monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2740 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/maternal prenatal monitor
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
K090285 also covers:
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 |
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Manufacturer
- Manufacturer
- Huntleigh Healthcare , Ltd.
Sources (1)
- FDA UDI 7dca807d-e2e6-45e9-b5bb-48eaf3773a0e 37 fields · synced May 31, 2026