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7D Surgical Pointer 11-0009

by 7D Surgical ULC

Ref 11-0009

7D Surgical Pointer 11-0009 is a device classified as Class III in the EU and Class II in the US made by 7D Surgical ULC, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-00628341520454) and listed in FDA GUDID since 17 Dec 2019 (UDI-DI 00628341520454), 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-00628341520454 Basic UDI-DI 00628341520454UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00628341520454 UDI-DI Date17 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00628341520454 registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 00628341520454 listed 17 Dec 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00628341520454
  2. Registered EUDAMED B-00628341520454

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  • Withdrawn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
7D Surgical Pointer
Generic name
Stereotactic surgery system probe, reusable
Model / reference
11-0009
Primary DI / UDI-DI
00628341520454
Basic UDI-DI
B-00628341520454
FDA product code
HAW, OLO
EMDN code
L1113 Neurosurgery burs and tips, reusable
GMDN term
Stereotactic surgery system probe, reusable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.4560
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Stereotactic surgery system probe, reusable

Similar devices in this category

Other devices filed under NEUROSURGERY BURS AND TIPS, REUSABLE.

Other devices from 7D Surgical ULC

See all devices from 7D Surgical ULC →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)