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Flexband non woven cohesive bandage (Latex free)

by Nanjing 3H Medical Products Co., Ltd. 2 variants

Ref rule1Model FBZN

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 Number697402141FBZN02BS Basic UDI-DI Date1 Mar 2022RegisteredStatusActive

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  • Withdrawn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

Trade Name
Flexband non woven cohesive bandage (Latex free)
Flexband non woven cohesive bandage
Device Name
cohesive bandage
Model / Reference
FBZN, rule1
Primary DI / UDI-DI
06974021411586, 06974021411579, 06974021411593, 06974021418639, 06974021412958, 06979191881573, 06974021411616
Basic UDI-DI
697402141FBZN02BS, 697402141FBZN01BQ
EMDN Code
M030402030102 Elastic support bandages, adhesive extensible in one direction, high extensibility
Device Class
Class I
EU market of registration
Slovenia
Germany
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000002303
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Nanjing 3H Medical Products Co., Ltd.

See all devices from Nanjing 3H Medical Products 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