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Spectrum Autopass

by Conmed Corporation

Ref SMI-02N, SMI-02AP

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10845854045756 Basic UDI-DI Date6 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845854045756 UDI-DI Date30 May 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Generic Name
Suturing needle, single-use
Device Name
Orthopedic, Non-active, Instrument, Suture Passer Needle, Spectrum
Orthopedic, Non-active, Reusable Surgical Instrument, Passing/Retrieval
Model / Ref / Catalog
SMI-02N, SMI-02AP
Primary DI / UDI-DI
10845854045756, 10845854042243
Basic UDI-DI
B-10845854045756, B-10845854042243
FDA Product Code
LXH
EMDN Code
H900899, L0299
GMDN Term
Suturing needle, single-use
Device Class
Class IIa EUDAMED
Class I EUDAMEDGUDID
Regulation Number
888.4540
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
Class I
GUDID
Class I
SterileEUDAMED
Yes
GUDID
Yes
No

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Sterile YesEUDAMEDGUDIDNoGUDID
  • Single Use NoGUDIDYesGUDID
  • Reusable NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number NoGUDIDYesGUDID
  • Serial Number YesGUDIDNoGUDID
  • Expiration Date NoGUDIDYesGUDID
  • Manufacturing Date YesGUDIDNoGUDID

Other properties (15)

  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No