← Back to catalogue

Sterile medical face mask

EUDAMED

Class I (EU MDR)

Ref 17.5*9.5cm Type IIRModel IsRef N/AModel Earloop type/Easy Ties type, 17.5*9.2cm

by Xiantao Fushi Protective Products Co., Ltd

Identity

Device Name
Sterile medical face mask EUDAMED
Disposable Medical Face Mask EUDAMED
Model / Reference
Is EUDAMED
17.5*9.5cm Type IIR EUDAMED
Earloop type/Easy Ties type, 17.5*9.2cm EUDAMED
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
06975063461041 EUDAMED
Basic UDI-DI
697506346ismasksN4 EUDAMED
B-06975063461041 EUDAMED
EMDN Code
T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Spain 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

Sterile medical face mask by Xiantao Fushi Protective Products Co., Ltd — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

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

Manufacturer

Manufacturer
Xiantao Fushi Protective Products Co., Ltd
EUDAMED SRN
CN-MF-000017275
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED 5820a02a-f1d9-48ae-8150-372331158b58 61 fields · synced Sep 17, 2026
  • EUDAMED 25f4e887-abfc-47b6-a893-3459647010ce 61 fields · synced May 18, 2026
  • EUDAMED 25f4e887-abfc-47b6-a893-3459647010ce-1 61 fields · synced Jun 9, 2026