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Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)

by BSN medical GmbH

510(k) K143151Ref 73285-01, 73285-02, 73285-00

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143151↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40428094004348399 Basic UDI-DI Date2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042809556339 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK143151 Date26 Jan 2015ClearedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Cutimed® Siltec®
Generic Name
Exudate-absorbent dressing, non-gel, non-antimicrobial
Device Name
Cutimed® Siltec® / Leukoplast® Cutimed ®Siltec®
Model / Ref / Catalog
73285-02, 73285-01, 73285-00
Primary DI / UDI-DI
04042809556339, 04042809556100, 04042809555851
Basic UDI-DI
40428094004348399
Unit of Use DI
04042809703429, 04042809703436, 04042809703443
510(k) Number
FDA Product Code
FRO 510(k)
NAC GUDID
EMDN Code
M04040601 Polyurethane dressings, non-combined
GMDN Term
Exudate-absorbent dressing, non-gel, non-antimicrobial
Device Class
Class IIb EUDAMED
U 510(k)
Class I GUDID
Regulation Number
878.4018
EU market of registration
Netherlands
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Size
Length — 20 Centimeter
Width — 10 Centimeter
Length — 10 Centimeter
Width — 5 Centimeter
Length — 6 Centimeter

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
FDA Product CodeEUDAMED
—
510(k)
FRO
GUDID
NAC
Device ClassEUDAMED
Class IIb
510(k)
U
GUDID
Class I

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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