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Single-use medical protective face mask

EUDAMED

Class I (EU MDR)

Ref M95Model Model: Folded type Specifications：N95-L, N95-M and N95-S

by Jiangxi Hongda Medical Equipment Group Ltd.

Identity

Trade Name
Single-use medical protective face mask EUDAMED
Device Name
Single-use medical protective face mask EUDAMED
Model / Reference
Model: Folded type Specifications：N95-L, N95-M and N95-S EUDAMED
M95 EUDAMED

Identifiers

Primary DI / UDI-DI
66920756700411 EUDAMED
Basic UDI-DI
69207567YYFHKZ0001VV EUDAMED
EMDN Code
T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Hungary EUDAMED

Clinical & Handling

Sterile

Yes

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

Single-use medical protective face mask by Jiangxi Hongda Medical Equipment Group Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Jiangxi Hongda Medical Equipment Group Ltd.
EUDAMED SRN
CN-MF-000006019
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 9fec9c1f-6f00-43b1-94cf-576538511ed9 61 fields · synced Oct 6, 2026