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Contec

FDA UDI

Class II (US FDA UDI)

by Contec Medical Systems Co., Ltd.

Identity

Trade Name
CONTEC FDA UDI
Generic Name
Blood pressure ambulatory recorder FDA UDI
Device Name
Automatic Blood Pressure Monitor FDA UDI
Model / Reference
ABPM50 FDA UDI
Description
Automatic Blood Pressure Monitor FDA UDI

Identifiers

Primary DI / UDI-DI
06945040106296 FDA UDI
510(k) Number
K202757 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood pressure ambulatory recorder

Contec by Contec Medical Systems Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood pressure ambulatory recorder.

Cleared under the same submission

K202757 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Contec Medical Systems Co., Ltd.

Sources (1)

  • FDA UDI 6e2cdfa4-b6e1-4b93-94ad-ba67565c7c19 34 fields · synced May 30, 2026