Skip to content

MaxMoreSpine 1001-ES 18

by Hoogland Spine Products, GmbH

Ref 1001-ES 18Model Working Sleeve

MaxMoreSpine 1001-ES 18 is a Class I device made by Hoogland Spine Products, GmbH, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-04260200311528) and listed in FDA GUDID since 1 Mar 2022 (UDI-DI 04260200311528), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04260200311528 Basic UDI-DI 04260200311528UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260200311528 UDI-DI Date1 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04260200311528 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 04260200311528 listed 1 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260200311528
  2. Registered EUDAMED B-04260200311528

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  • Withdrawn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
Working Sleeve 8,5 mm EUDAMED
MaxMoreSpine GUDID
Generic name
Endoscope sheath, reusable
Model / reference
1001-ES 18, Working Sleeve
Primary DI / UDI-DI
04260200311528
Basic UDI-DI
B-04260200311528
FDA product code
FZX
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
GMDN term
Endoscope sheath, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscope sheath, reusable

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER.

Other devices from Hoogland Spine Products, GmbH

See all devices from Hoogland Spine Products, GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)