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Mediblu

FDA UDI

Class II (US FDA UDI)

by Mediblu Medical, LLC

Identity

Trade Name
Mediblu FDA UDI
Generic Name
Foetal Doppler system FDA UDI
Model / Reference
FD1 FDA UDI

Identifiers

Catalog Number
MDB01009 FDA UDI
Primary DI / UDI-DI
B632MDB01009 FDA UDI
FDA Product Code
HEP FDA UDI
GMDN Term
Foetal Doppler system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.2660 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
MRI Safety
MR Unsafe FDA UDI

Category: Foetal Doppler system

Mediblu by Mediblu Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Foetal Doppler system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI bd229399-d78b-45b0-b524-73fb6808f01d 34 fields · synced Jun 1, 2026