← Back to catalogue

Disposable medical face mask- tie-on

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref Disposable medical face mask- tie-onModel Disposable medical face mask- ear-loop, Disposable medical face mask- tie-on

by Carestone Medical & Protective Products Co., Ltd.

Identity

Trade Name
Disposable medical face mask- tie-on EUDAMED
Device Name
Disposable medical face mask EUDAMED
Model / Reference
Disposable medical face mask- ear-loop, Disposable medical face mask- tie-on EUDAMED
Disposable medical face mask- tie-on EUDAMED

Identifiers

Primary DI / UDI-DI
00697549344063 EUDAMED
Basic UDI-DI
697549344MASKSTT EUDAMED
Direct Marketing DI
00697549344063 EUDAMED
EMDN Code
T020603 MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Disposable medical face mask- tie-on by Carestone Medical & Protective Products Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Carestone Medical & Protective Products Co., Ltd.
EUDAMED SRN
CN-MF-000027756
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (2)

  • EUDAMED 273d3313-fed3-44f4-ae4f-3d118816ffb6 61 fields · synced Oct 6, 2026
  • FDA 510(k) K211462 1 fields · synced May 18, 2026