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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 blood pressure ambulatory recorder FDA UDI
Device Name
WatchBP O3 2G(BP3SZ1-1) CBP type FDA UDI
Model / Reference
BP3SZ1-1CEN FDA UDI
Description
WatchBP O3 2G(BP3SZ1-1) CBP type FDA UDI

Identifiers

Catalog Number
WatchBP O3 2G FDA UDI
Primary DI / UDI-DI
04719003315047 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Arrythmia-detection blood pressure ambulatory recorder 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
MRI Safety
MR Unsafe FDA UDI

Category: Arrythmia-detection blood pressure ambulatory recorder

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

Similar devices

Also classified as Arrythmia-detection blood pressure ambulatory recorder.

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 945668fa-84ce-49ba-ac0b-971483df7665 34 fields · synced May 30, 2026