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BIATAIN Alginate Ag

by Advanced Medical Solutions Limited 4 variants

Ref 3765

BIATAIN Alginate Ag (376539980) is a device classified as Class III (EU), Unclassified (US) made by Advanced Medical Solutions Limited, registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI B-05032749032627), cleared under FDA 510(k) K090453 on 26 Feb 2009 and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 05032749032627), active as of 25 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090453

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05032749032627 Basic UDI-DI 05032749032627UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032749032627 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK090453 Date26 Feb 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05032749032627 registered 21 Aug 2026 Active
  • FDA 510(k) K090453 decided 26 Feb 2009 Active
  • FDA GUDID UDI-DI 05032749032627 listed 7 Dec 2022 Listed

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1806-2022 FDA Class III initiated 25 May 2022
    • Ongoing Z-1805-2022 FDA Class III initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

    • Terminated Z-2719-2016 FDA Class II initiated 15 Jan 2015

    On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse

Timeline

6 dated events

  1. Cleared FDA 510(k) K090453
  2. Recall initiated FDA recalls Z-2719-2016
  3. Recall initiated FDA recalls Z-1806-2022
  4. Recall initiated FDA recalls Z-1805-2022
  5. Listed FDA GUDID 05032749032627
  6. Registered EUDAMED B-05032749032627

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Biatain
Generic name
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Device name
Biatain Alginate Ag - 15x15cm
Model / Ref / Catalog
3765 EUDAMED
Alginate Ag GUDID
376539980 GUDID
Primary DI / UDI-DI
05032749032627
Basic UDI-DI
B-05032749032627
510(k) Number
FDA product code
FRO
EMDN code
M04040802 Silver dressings, combined with other substances
GMDN term
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Device class
Class III EUDAMED
U GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
3765
GUDID
Alginate Ag
Device classEUDAMED
Class III
GUDID
U

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Cleared under the same submission (K090453)

and 8 more cleared under K090453

Similar devices in this category

Other devices filed under SILVER DRESSINGS.

Other devices from Advanced Medical Solutions Limited

See all devices from Advanced Medical Solutions Limited →

Properties

  • Supplied sterile
  • Single use
  • Incorporates a medicinal substance
  • Prescription use
  • Combination product
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)