Disposable Medical Face Mask

by Xinxiang Tianhong Medical Device Co., Ltd.

Ref flat ear-loop mask 17.5cm×9.5cmModel "A: flat ear-loop mask B: flat tie-on mask 17.5cm×9.5cm, 14.5cm×9.5cm, 12.5cm×9.5cm, 12cm×7cm, other sizes customizable upon request"

Active European Union

CE MDR

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

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69354722MEDICALFACEMASKPF Basic UDI-DI 06935472200006UDI-DI	Date12 Jun 2025Registered	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Withdrawn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/MDR Active

Specification

EUDAMED

Device Name: Disposable Medical Face Mask
Model / Reference: "A: flat ear-loop mask B: flat tie-on mask 17.5cm×9.5cm, 14.5cm×9.5cm, 12.5cm×9.5cm, 12cm×7cm, other sizes customizable upon request", flat ear-loop mask 17.5cm×9.5cm

Primary DI / UDI-DI: 06935472200006
Basic UDI-DI: 69354722MEDICALFACEMASKPF
EMDN Code: T020604 Medical use face masks, type II and iir

Device Class: Class I
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000009219
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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Properties

Other properties (13)

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
Measuring Function: No
Incorporates Medicinal Product: No