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Biatain Silicone Fit 37538

by Coloplast A/S

Ref 37538

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Overview

The Biatain Silicone Fit exudate-absorbent dressing is a non-gel, non-antimicrobial dressing designed for wound healing. It provides a moist environment that absorbs and removes exudates, promoting wound healing.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5708932122229142GE Basic UDI-DI Date19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05701780402361 UDI-DI Date22 Dec 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Biatain Silicone Fit
Generic Name
Exudate-absorbent dressing, non-gel, non-antimicrobial
Device Name
Biatain Silicone Fit foam dressing
Model / Ref / Catalog
37538
Primary DI / UDI-DI
05701780402361 EUDAMED
05701780421874 EUDAMED
05708932761406 GUDID
Basic UDI-DI
5708932122229142GE
Unit of Use DI
05701780402354, 05701780421867
FDA Product Code
NAD
EMDN Code
M04040701 Silicone dressings, non-combined
GMDN Term
Exudate-absorbent dressing, non-gel, non-antimicrobial
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
878.4020
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 7.5 Centimeter
Width — 7.5 Centimeter
Length — 3 Inch
Width — 3 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05701780402361
05701780421874
GUDID
05708932761406
Device ClassEUDAMED
Class IIb
GUDID
Class I

Related devices

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

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No