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HEPRO.US MM1000 Blood Glucose Monitoring System Kit

FDA UDI

Class I (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name
HEPRO.US MM1000 Blood Glucose Monitoring System Kit FDA UDI
Generic Name
Glucose/haematocrit monitoring system IVD, home-use FDA UDI
Device Name
Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lancets, 1 logbook, 1 user manual FDA UDI
Model / Reference
KIT - Glucose Monitoring System FDA UDI
Description
Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lancets, 1 logbook, 1 user manual FDA UDI

Identifiers

Primary DI / UDI-DI
00854427007148 FDA UDI
FDA Product Code
JJX FDA UDI
CGA FDA UDI
NBW FDA UDI
GMDN Term
Glucose/haematocrit monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
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

HEPRO.US MM1000 Blood Glucose Monitoring System Kit by Hepro.us Inc. — Class I — 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 9c3aa190-e42c-4670-82d6-4317a4198256 33 fields · synced May 30, 2026