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PowerFlex 5yard

by Andover Healthcare Inc. 13 variants

Ref 3815GR-048Model PowerFlex 5yard

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 Number0724004PowerFlex5yardAX Basic UDI-DI 00724004385122UDI-DIDate27 Mar 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  • Withdrawn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
Coflex
Model / Reference
PowerFlex 5yard, 3815GR-048
Primary DI / UDI-DI
00724004385122
Basic UDI-DI
0724004PowerFlex5yardAX
EMDN Code
M030402020101 Elastic support bandages, cohesive, extensible in one direction, high extensibility
Device Class
Class I
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
US-MF-000035055
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Andover Healthcare Inc.

See all devices from Andover Healthcare Inc. →

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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