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MaxMoreSpine 1001-IS 004

by Hoogland Spine Products, GmbH

Ref 1001-IS 004Model PTFE Teflon

MaxMoreSpine 1001-IS 004 is a device classified as Class I in the EU and Class II in the US made by Hoogland Spine Products, GmbH, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 426020031MaxmoreTefFiDC) and listed in FDA GUDID since 1 Mar 2022 (UDI-DI 04260200310866), 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 Number426020031MaxmoreTefFiDC Basic UDI-DI 04260200310866UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260200310866 UDI-DI Date1 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426020031MaxmoreTefFiDC registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 04260200310866 listed 1 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260200310866
  2. Registered EUDAMED 426020031MaxmoreTefFiDC

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  • Withdrawn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
PTFE Teflon EUDAMED
MaxMoreSpine GUDID
Generic name
Sterilization container filter, single-use
Model / reference
1001-IS 004, PTFE Teflon
Primary DI / UDI-DI
04260200310866
Basic UDI-DI
426020031MaxmoreTefFiDC
FDA product code
KCT
EMDN code
S010402 Filters for sterilisation containers
GMDN term
Sterilization container filter, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Sterilization container filter, single-use

Similar devices in this category

Other devices filed under CONTAINERS FOR STERILISATION.

Other devices from Hoogland Spine Products, GmbH

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Properties

  • Sterilise before use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)