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Incrediwear® Bandage Wrap

by Incrediwear Holdings, Inc.

Ref BW105, BW101

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 Number0891709000WRAP6V Basic UDI-DI Date10 Nov 2021RegisteredStatusActive

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  • Withdrawn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
Wrap
Model / Reference
BW105, BW101
Primary DI / UDI-DI
00858349003769, 00858349003752
Basic UDI-DI
0891709000WRAP6V
EMDN Code
M030402010103 Elastic support bandages, non-adhesive, extensible in two directions, high extensibility
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000012639
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Incrediwear Holdings, Inc.

See all devices from Incrediwear Holdings, Inc. →

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