Saliva collector

by Jiangsu Comeon Medical Apparatus Co., Ltd 13 variants

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Overview

The Saliva Collector is a high-quality, FDA-cleared device designed to accurately and safely collect saliva samples for diagnostic and research purposes. By leveraging advanced technologies such as container packaging and endocrine disruptors, this device provides reliable results for various medical applications.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697563134KM001FQ Basic UDI-DI 16975631341017UDI-DI	Date14 Sep 2022Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Primary DI / UDI-DI: 16975631341017
Basic UDI-DI: 697563134KM001FQ
EMDN Code: W05019002 Saliva collection devices

Device Class: Class A
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000018384
Authorised representative: Sungo Cert GmbH DE-AR-000010869

Other devices from Jiangsu Comeon Medical Apparatus Co., Ltd

Saliva collector

Class A
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Class A
Centrifugal tube

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Virus sampling tube

Class A
Suction head

Class A
Freezing tube

Class A

See all devices from Jiangsu Comeon Medical Apparatus Co., Ltd →

Properties

Professional Testing

Other properties (10)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Reagent: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No