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PolyMem Silver Surgical

by Ferris Mfg. Corp. 2 variants

Ref 1511

PolyMem Silver Surgical (1511) is a device classified as Class IIb (EU), Unclassified (US) made by Ferris Mfg. Corp., registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-10735471015112) and listed in FDA GUDID since 31 Aug 2020 (UDI-DI 10735471015112), active as of 25 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10735471015112 Basic UDI-DI 10735471015112UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10735471015112 UDI-DI Date31 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10735471015112 registered 16 Sep 2026 Active
  • FDA GUDID UDI-DI 10735471015112 listed 31 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10735471015112
  2. Registered EUDAMED B-10735471015112

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
PolyMem Surgical Silver Adhesive Flexible Knee Dressing EUDAMED
PolyMem GUDID
Generic name
Wound-nonadherent dressing, absorbent, antimicrobial
Model / Ref / Catalog
1511, Silver Surgical
Primary DI / UDI-DI
10735471015112
Basic UDI-DI
B-10735471015112
FDA product code
FRO
EMDN code
M04040802 Silver dressings, combined with other substances
GMDN term
Wound-nonadherent dressing, absorbent, antimicrobial
Device class
Class IIb 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 Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1511
GUDID
Silver Surgical
Device classEUDAMED
Class IIb
GUDID
U

Device class is stated on each registry's own scale: Class IIb 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: Wound-nonadherent dressing, absorbent, antimicrobial

Similar devices in this category

Other devices filed under SILVER DRESSINGS.

Other devices from Ferris Mfg. Corp.

See all devices from Ferris Mfg. Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
Other properties (20, all answered No)