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Fluorinated Foam

by Nagy Oral Technology Qinhuangdao Co., Ltd. 4 variants

Ref FF-CE-A-125gModel Model:Type A (1.23%), Type C (0.6%)； Specifications:6g,10g,20g,30g,42g,125g,6ml,10ml,20ml,30ml,42ml,125ml;

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697272229FFZR Basic UDI-DI 06972722290967UDI-DIDate21 Jul 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Model:Type A (1.23%), Type C (0.6%)； Specifications:6g, 10g, 20g, 30g, 42g, 125g, 6ml, 10ml, 20ml, 30ml, 42ml, 125ml, FF-CE-A-125g
Primary DI / UDI-DI
06972722290967
Basic UDI-DI
697272229FFZR
EMDN Code
Q019007 Buccal topical treatment preparations not included in other classes
Device Class
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000020551
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Nagy Oral Technology Qinhuangdao Co., Ltd.

Properties

Other properties (13)

  • 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