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MaxMoreSpine 1001-BD 001

by Hoogland Spine Products, GmbH

Ref 1001-BD 001Model Bone Drill

MaxMoreSpine 1001-BD 001 is a bone trephine (EU MDD Class IIa; FDA Class I; FDA product code HTW, Bit, Drill) made by Hoogland Spine Products, GmbH, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-04260200310095) and listed in FDA GUDID since 28 Feb 2022 (UDI-DI 04260200310095), 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-04260200310095 Basic UDI-DI 04260200310095UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260200310095 UDI-DI Date28 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04260200310095 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 04260200310095 listed 28 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260200310095
  2. Registered EUDAMED B-04260200310095

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  • Withdrawn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
Manual Bone Drill 4 mm EUDAMED
MaxMoreSpine GUDID
Generic name
Bone trephine, reusable
Model / reference
1001-BD 001, Bone Drill
Primary DI / UDI-DI
04260200310095
Basic UDI-DI
B-04260200310095
FDA product code
HTW
EMDN code
Z12130503 Orthopaedic surgical drills
GMDN term
Bone trephine, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa 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: Bone trephine, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGICAL DRILLS.

Other devices from Hoogland Spine Products, GmbH

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Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)