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Airlock® XPP01003

by Novastep

Ref XPP01003

Airlock XPP01003 is a cannulated surgical drill bit (EU MDR Class IIa; FDA Class I; FDA product code HWE, Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment) made by Novastep, registered in EUDAMED on 11 Aug 2026 (Basic UDI-DI 370087950TF2A04010007T) and listed in FDA GUDID since 5 Dec 2019 (UDI-DI 03700879501857), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number370087950TF2A04010007T Basic UDI-DI 03700879501857UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700879501857 UDI-DI Date5 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 370087950TF2A04010007T registered 11 Aug 2026 Active
  • FDA GUDID UDI-DI 03700879501857 listed 5 Dec 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700879501857
  2. Registered EUDAMED 370087950TF2A04010007T

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  • Withdrawn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
Airlock®
Generic name
Cannulated surgical drill bit, reusable
Device name
Wires for orthopaedic surgery: MDS1006. Reusable
Model / Ref / Catalog
XPP01003
Primary DI / UDI-DI
03700879501857
Basic UDI-DI
370087950TF2A04010007T
Direct marketing DI
03700879501857
FDA product code
HWE
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Cannulated surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
France
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 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: Cannulated surgical drill bit, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Novastep

  • airlock® SP014014

    Class II

  • airlock® SP014016

    Class II

  • airlock® SP014018

    Class II

  • airlock® SP014022

    Class II

See all devices from Novastep →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)