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1120

by Advanced Neuromodulation Systems

Part of a family of 48 devices: see the family page

Ref 1120

1120 is a device classified as Class III in the EU and Class I in the US made by Advanced Neuromodulation Systems, registered in EUDAMED on 29 Jun 2026 (Basic UDI-DI 5415067SCS0001L4) with CE/MDR certificate MDR 750959 valid until 11 Oct 2027 and listed in FDA GUDID since 23 Oct 2014 (UDI-DI 05414734400176), active as of 25 Oct 2026.

Expiring European Union. Also listed in GUDID (US).

CE MDR

Valid until

11 Oct 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067SCS0001L4 Basic UDI-DI 05414734400176UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734400176 UDI-DI Date23 Oct 2014ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5415067SCS0001L4 registered 29 Jun 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05414734400176 listed 23 Oct 2014 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 750959 Expiring Supplemented Expires in 333 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    24 Jun 2026
    Expires
    11 Oct 2027
    Reason
    Add device or group

Timeline

4 dated events

  1. Listed FDA GUDID 05414734400176
  2. Certificate issued EUDAMED MDR 750959
  3. Registered EUDAMED 5415067SCS0001L4
  4. Certificate expires EUDAMED MDR 750959

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Tendon/ligament tunneller
Device name
Spinal Cord Stimulation
Model / Ref / Catalog
1120
Primary DI / UDI-DI
05414734400176
Basic UDI-DI
5415067SCS0001L4
FDA product code
HAO
EMDN code
J020280 Spinal implantable neurostimulators - accessories
GMDN term
Tendon/ligament tunneller
Device class
Class III EUDAMED
Class I GUDID
Regulation number
882.4535
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 20 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class I
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class III 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: Tendon/ligament tunneller

Similar devices in this category

Other devices filed under SPINAL IMPLANTABLE NEUROSTIMULATORS.

Other devices from Advanced Neuromodulation Systems

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See all devices from Advanced Neuromodulation Systems →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)