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Face mask

by Hubei Qifu Protective Products Co., Ltd EUDAMEDGUDID

Active European Union

Ref 14.5cmx9cmModel 17.5cm x9.5cm, 14.5cmx9cm

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975089780010 UDI-DIDate23 Dec 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697508978FaceMask001YF Basic UDI-DIDate20 Feb 2025RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Disposable Face Mask
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use
Device Name
Face mask
Model / Reference
17.5cm x9.5cm EUDAMED
14.5cmx9cm EUDAMED
17.5x9.5CM GUDID
Primary DI / UDI-DI
06975089780010
Basic UDI-DI
697508978FaceMask001YF
FDA Product Code
QKR
EMDN Code
T020604 Medical use face masks, type II and iir
GMDN Term
Surgical/medical face mask, non-antimicrobial, single-use
Device Class
Class I EUDAMED
N GUDID
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
17.5cm x9.5cm, 14.5cmx9cm
14.5cmx9cm
GUDID
17.5x9.5CM
Device ClassEUDAMED
Class I
GUDID
N

Manufacturer details

EUDAMED SRN
CN-MF-000002318
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hubei Qifu Protective Products Co., Ltd

See all devices from Hubei Qifu Protective Products Co., Ltd →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No