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Surgical Face Mask

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref JHFM020Model FM-III-IRef JHFM004-23Ref VI14003

by Hubei Qianjiang Kingphar Medical Material Co., Ltd

Identity

Trade Name
Surgical Face Mask EUDAMED
Device Name
Surgical Face Mask EUDAMED
Model / Reference
FM-III-I EUDAMED
JHFM020 EUDAMED
JHFM004-23 EUDAMED
VI14003 EUDAMED

Identifiers

Primary DI / UDI-DI
06948788161442 EUDAMED
06948788160322 EUDAMED
06948788166607 EUDAMED
Basic UDI-DI
694878811006PY EUDAMED
Secondary DI
04251873710022 EUDAMED
EMDN Code
T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED
Spain 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

Surgical Face Mask by Hubei Qianjiang Kingphar Medical Material 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

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Manufacturer

Manufacturer
Hubei Qianjiang Kingphar Medical Material Co., Ltd
EUDAMED SRN
CN-MF-000009051
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED cf84a8d3-922d-4293-8c9f-57167547fa80 61 fields · synced Oct 6, 2026
  • EUDAMED ffe7d99f-8137-4f4f-8d69-c83ee16f4917 61 fields · synced May 17, 2026
  • EUDAMED 1b5a10a0-043e-4ca6-a247-8f97bffdc267 61 fields · synced Jul 8, 2026
  • FDA 510(k) K220777 1 fields · synced May 18, 2026