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Microlife

FDA UDI

Class II (US FDA UDI)

by Microlife Usa, Inc.

Identity

Trade Name
Microlife FDA UDI
Generic Name
Arrythmia-detection sphygmomanometer FDA UDI
Device Name
WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets FDA UDI
Model / Reference
CRO-BP3MX1-3C1 FDA UDI
Description
WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets FDA UDI

Identifiers

Primary DI / UDI-DI
04719003315085 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Arrythmia-detection sphygmomanometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Arrythmia-detection sphygmomanometer

Microlife by Microlife Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arrythmia-detection sphygmomanometer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microlife Usa, Inc.

Sources (1)

  • FDA UDI 21a94dda-8265-4698-a149-b20806712cbd 33 fields · synced Jun 1, 2026