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PolyMem Shapes

by Ferris Mfg. Corp. 2 variants

Ref 5335

PolyMem Shapes (5335) is a device classified as Class IIb in the EU and Class I in the US made by Ferris Mfg. Corp., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 07354710134M) and listed in FDA GUDID since 31 Aug 2020 (UDI-DI 10735471053350), active as of 7 Nov 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07354710134M Basic UDI-DI 10735471053350UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10735471053350 UDI-DI Date31 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 07354710134M registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 10735471053350 listed 31 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10735471053350
  2. Registered EUDAMED 07354710134M

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  • Withdrawn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
Shapes Tube Dressing EUDAMED
PolyMem GUDID
Generic name
Tracheostomy tube dressing
Model / Ref / Catalog
5335, Shapes
Description
3.5" x 3.5" Shapes by PolyMem Tube Dressing
Primary DI / UDI-DI
10735471053350
Basic UDI-DI
07354710134M
FDA product code
KMF
EMDN code
M04040602 Polyurethane dressings, combined with other substances
GMDN term
Tracheostomy tube dressing
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
880.5090
EU registration type
Standard device
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
5335
GUDID
Shapes
Device classEUDAMED
Class IIb
GUDID
Class I

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

Related devices

Category: Tracheostomy tube dressing

Similar devices in this category

Other devices filed under POLYURETHANE DRESSINGS.

Other devices from Ferris Mfg. Corp.

See all devices from Ferris Mfg. Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
Other properties (22, all answered No)