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Varisan Flat

by Cizeta Medicali S.P.A. 99 variants

Ref FL4E1-604-4, FL4E19-862-14, FL3N9-604-8, FL3N9-862-10, FN449-420-S, FL3E1-604-4, FN447-862-M, FL4N9-604-6, FL5N9-420-6, FN447-604-XL, FL3E1-862-8, FL5E9-604-6, FL4E9-604-8, FL3E1-604-14, FL4E9-604-12, FE447-820-M, FL5E1-604-4, FL3E9-604-6, FL4E19-862-12, FM5E9-604-6, SN447-862-L, FE449-604-S, FL3N9-862-8, FL5E9-862-4, FN449-440-XS, FL4N19-604-6, FL5N9-862-8, FE447-608-M, FE447-604-XS, FL4E1-545-8, FL4N1-450-10, FL4E19-604-6, FL4N1-545-10, FL4E1-862-10, FL4E1-862-8, FN447-604-M, FE449-535-M, FN449-604-L, FL4E9-604-10, FL4N19-862-12, FL3N1-608-8, FE449-604-M, FL4N19-604-14, FE447-604-S, FL4N1-545-12, FL4E19-604-4, FL5N1-604-4, FB4E1-862-8, FL443-604-S, FB4E1-106-12, FL443-545-S

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805243924FLATK2_HN Basic UDI-DI Date16 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Varisan Flat
Model / Reference
FL4E1-604-4, FL4E19-862-14, FL3N9-604-8, FL3N9-862-10, FN449-420-S, FL3E1-604-4, FN447-862-M, FL4N9-604-6, FL5N9-420-6, FN447-604-XL, FL3E1-862-8, FL5E9-604-6, FL4E9-604-8, FL3E1-604-14, FL4E9-604-12, FE447-820-M, FL5E1-604-4, FL3E9-604-6, FL4E19-862-12, FM5E9-604-6, SN447-862-L, FE449-604-S, FL3N9-862-8, FL5E9-862-4, FN449-440-XS, FL4N19-604-6, FL5N9-862-8, FE447-608-M, FE447-604-XS, FL4E1-545-8, FL4N1-450-10, FL4E19-604-6, FL4N1-545-10, FL4E1-862-10, FL4E1-862-8, FN447-604-M, FE449-535-M, FN449-604-L, FL4E9-604-10, FL4N19-862-12, FL3N1-608-8, FE449-604-M, FL4N19-604-14, FE447-604-S, FL4N1-545-12, FL4E19-604-4, FL5N1-604-4, FB4E1-862-8, FL443-604-S, FB4E1-106-12, FL443-545-S
Primary DI / UDI-DI
08052439246209, 08053484216452, 08053484212607, 08053484213796, 08053484212331, 08053484210764, 08053484200208, 08052439246391, 08053484212713, 08052439245561, 08053484205548, 08052439246810, 08052439246346, 08053484212409, 08052439246360, 08053484212911, 08052439246681, 08053484212317, 08053484212232, 08053484213802, 08053484212812, 08052439246988, 08053484213369, 08053484218340, 08053484205654, 08053484216483, 08053484205029, 08053484212294, 08052439242614, 08053484204534, 08053484218289, 08053484211181, 08053484205128, 08053484212423, 08053484210757, 08052439246964, 08053484199946, 08052439247039, 08052439246353, 08053484216568, 08053484212942, 08052439246995, 08053484211235, 08052439246926, 08053484204893, 08053484210979, 08052439246742, 08053484213314, 08052439247046, 08053484210870, 08053484206262
Basic UDI-DI
805243924FLATK2_HN, 8053484FLAT3P, 805243924VARISANFLATBK, 805348420VARISANFLAT9E, 805243924FLATK3_HR, 8053484FLATK2_VZ, 803263897VARISANFLATN6
EMDN Code
M030405, M030499
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028355

Related devices

Category: Compression/pressure sock/stocking, single-use

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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