RedDrop Dx

FDA UDI

Class II (US FDA UDI)

by Reddrop DX

Identity

Trade Name: RedDrop Dx FDA UDI
Generic Name: Manual blood lancing device, single-use FDA UDI
Device Name: The RedDrop One is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples. FDA UDI
Model / Reference: 300-25-007 FDA UDI
Description: The RedDrop One is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860011954002 FDA UDI
510(k) Number: K234081 FDA UDI
FDA Product Code: FMK FDA UDI
GMDN Term: Manual blood lancing device, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Manual blood lancing device, single-use

RedDrop Dx by Reddrop DX — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K234081 also covers:

RedDrop One — Reddrop DX

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: Reddrop DX

Sources (1)

FDA UDI 0ec3a726-7913-4c72-b4f2-b90732b73b2e 34 fields · synced Jun 6, 2026