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Zoellner Micro Ear Knife Angled Upwards Stainless Steel

by Surtex Instruments Ltd United Kingdom EUDAMEDGUDID

Ref OT-535-12Model 50554459SCPLANDKIRL0102EB

Product code EMFEMDN L0102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05055445969868 UDI-DIDate12 May 2026ListedStatusIn distribution
European UnionCE/MDD EUDAMED Number50554459CUTTINGINSTRL2 Basic UDI-DIDate13 Mar 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number50554459CUTTINGINSTRL2 Basic UDI-DIDate13 Mar 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Zoellner Micro Ear Knife Angled Upwards Stainless Steel EUDAMED
Surtex GUDID
Generic Name
Ear knife
Device Name
Cutting Instruments
Surgical knives, reusable
Model / Reference
OT-535-12, 50554459SCPLANDKIRL0102EB
Primary DI / UDI-DI
05055445969868
Basic UDI-DI
50554459CUTTINGINSTRL2, B-05055445969868
FDA Product Code
EMF
EMDN Code
L0102 Surgical knives, reusable
GMDN Term
Ear knife
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Spain
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Manufacturer details

EUDAMED SRN
GB-MF-000023183
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Surtex Instruments Ltd

See all devices from Surtex Instruments Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
  • Premarket Exempt
Other properties (22)
  • Sterile: No
  • Single Use: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 5e21d0f6-3786-4ae0-b031-91555cd1b368 61 fields · synced 22 Oct 2026
  • EUDAMED 05055445969868|B-05055445969868 61 fields · synced 10 Oct 2026
  • FDA UDI 989b1381-fd43-46f9-9a8b-111e20f6832b 34 fields · synced 22 Oct 2026