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Glucose Test Strip 50 Ct.

FDA UDI

Class II (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name
GLUCOSE TEST STRIP 50 CT. FDA UDI
Generic Name
Glucose/haematocrit monitoring system IVD, home-use FDA UDI
Device Name
HEPRO.US GLUCOSE TEST STRIPS 50units/BX for MM1000 FDA UDI
Model / Reference
GLUCOSE TEST STRIP 50 CT. FDA UDI
Description
HEPRO.US GLUCOSE TEST STRIPS 50units/BX for MM1000 FDA UDI

Identifiers

Primary DI / UDI-DI
00850578007044 FDA UDI
FDA Product Code
NBW FDA UDI
GMDN Term
Glucose/haematocrit monitoring system IVD, home-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Glucose/haematocrit monitoring system IVD, home-use

Glucose Test Strip 50 Ct. by Hepro.us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose/haematocrit monitoring system IVD, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hepro.us Inc.

Sources (1)

  • FDA UDI 81328e01-9880-44d7-86d6-4d22685fa1f6 33 fields · synced Jun 8, 2026