Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Glucose monitoring system IVD, point-of-care FDA UDI
Device Name: Curaplex Blood Glucose Meter FDA UDI
Model / Reference: 2761-32701 FDA UDI
Description: Curaplex Blood Glucose Meter FDA UDI

Identifiers

Catalog Number: 2761-32701 FDA UDI
Primary DI / UDI-DI: 00812277030013 FDA UDI
510(k) Number: K082965 FDA UDI
FDA Product Code: NBW FDA UDI
GMDN Term: Glucose monitoring system IVD, point-of-care FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose monitoring system IVD, point-of-care

Curaplex by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose monitoring system IVD, point-of-care.

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StatSensor/StatStrip — NOVA BIOMEDICAL CORPORATION · Class II
Nova — NOVA BIOMEDICAL CORPORATION · Class II
Fresh Test — Fresh Test, LLC · Class II
GlucoLeader Enhance Blood Glucose Monitoring System(BR/BMT) — Hmd Biomedical, LLC · Class II
CURO L5 — KPI HEALTHCARE, INC. · Class II

Cleared under the same submission

K082965 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: Bound Tree Medical, Llc

Sources (1)

FDA UDI 1b64e155-e311-4b79-a349-4609fec67990 36 fields · synced May 30, 2026