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UBZ White SINGLE Roll 4"X6

by Andover Healthcare Inc.

Ref UB840Z-01Model CoFlex TLC Single Zinc

UBZ White SINGLE Roll 4"X6 (UB840Z-01) is a Class I device made by Andover Healthcare Inc., registered in EUDAMED on 15 Apr 2026 (Basic UDI-DI 0724004COFLEXTLCSNGLZNMD) and listed in FDA GUDID since 5 Apr 2022 (UDI-DI 00724004613676), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724004COFLEXTLCSNGLZNMD Basic UDI-DI 00724004613676UDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724004613676 UDI-DI Date5 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724004COFLEXTLCSNGLZNMD registered 15 Apr 2026 Active
  • FDA GUDID UDI-DI 00724004613676 listed 5 Apr 2022 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 00724004613676
  2. Registered EUDAMED 0724004COFLEXTLCSNGLZNMD

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
CoFlex TLC Single Zinc EUDAMED
Ubz GUDID
Generic name
Compression bandaging kit
Device name
Coflex Tlc
Model / Ref / Catalog
CoFlex TLC Single Zinc, UB840Z-01, White SINGLE Roll 4"X6
Description
Unna Boot Zinc A single roll of soft foam impregnated with Zinc. White SINGLE Roll 4"X6
Primary DI / UDI-DI
00724004613676 EUDAMED
10724004613673 GUDID
Basic UDI-DI
0724004COFLEXTLCSNGLZNMD
FDA product code
KGX
EMDN code
M03040299 Elastic support bandages - other
GMDN term
Compression bandaging kit
Device class
Class I
Regulation number
880.5240
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CoFlex TLC Single Zinc
UB840Z-01
GUDID
White SINGLE Roll 4"X6
Primary DI / UDI-DIEUDAMED
00724004613676
GUDID
10724004613673

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00724004613676; FDA GUDID lists 10724004613673), so their flags are not compared.

Similar devices in this category

Other devices filed under ELASTIC SUPPORT BANDAGES - OTHER.

Other devices from Andover Healthcare Inc.

See all devices from Andover Healthcare Inc. →

Properties

  • Single use
  • Contains animal tissues or cells
  • Incorporates a medicinal substance
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)