What models are included in this series?

The product line consists of the PG-800A series and the PG-800B series of electronic blood pressure monitors.

Is this device sterile?

No, the device is not sterile and is not classified as an implantable medical device.

Electronic Blood Pressure Monitor

by Shenzhen Pango Medical Electronics Co., Ltd

Ref Z1203020302Model PG-800A series，PG-800Bseries

Active European Union and United States

CE MDR 510(k)

Valid until

25 Jul 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K223291↗

+6 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number28620184373-02	Date20 Aug 2026Issued	StatusActive expires 25 Jul 2029
European Union	CE/MDR EUDAMED	Number6948423813149BB Basic UDI-DI 06948423809913UDI-DI	Date23 Apr 2025Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK223291	Date14 Jun 2023Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK200716	Date4 Dec 2020Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK170151	Date13 Oct 2017Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK161845	Date31 Jul 2017Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK131569	Date14 Jun 2013Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK102988	Date9 Nov 2010Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK102920	Date15 Oct 2010Issued	StatusActive

Certificates

1 certificate · EUDAMED

28620184373-02 Active Supplemented

Quality management system EU MDR

Certifier

Intertek Medical Notified Body AB 2862

Issued
20 Aug 2026

Expires
25 Jul 2029

Reason
Other

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / Reference: PG-800A series，PG-800Bseries, Z1203020302

Primary DI / UDI-DI: 06948423809913
Basic UDI-DI: 6948423813149BB
EMDN Code: Z1203020302 Non–invasive blood pressure monitoring instruments

Device Class: Class IIa
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: CN-MF-000023018
Authorised representative: Lotus NL B.V. NL-AR-000000121

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Electronic Blood Pressure Monitor is a medical device designed to measure blood pressure. It is manufactured by Shenzhen Pango Medical Electronics Co., Ltd and is identified by the reference code Z1203020302.

This device is classified as Class IIa and features a measuring function. It is supplied as a non-sterile, non-implantable product and is not intended for the administration of medicine. The monitor is available in the PG-800A and PG-800B series models.

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See all devices from Shenzhen Pango Medical Electronics Co., Ltd →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

What models are included in this series?

The product line consists of the PG-800A series and the PG-800B series of electronic blood pressure monitors.
Is this device sterile?

No, the device is not sterile and is not classified as an implantable medical device.
Who is the manufacturer of this monitor?

The monitor is manufactured by Shenzhen Pango Medical Electronics Co., Ltd, based in Shenzhen, China.

Properties

Measuring Function

Other properties (12)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Incorporates Medicinal Product: No