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Diamond Phaco Knife Angled - Spear Shaped 13 cm - 5" Blade Width 3.2 mm Titanium Handle

by Surtex Instruments Ltd

Ref OP-341-32Model 50554459SCPLANDKIRL0102EB

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

CE MDR 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05056111301586 UDI-DIDate12 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED Number50554459CUTTINGINSTRL2 Basic UDI-DIDate13 Mar 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number50554459CUTTINGINSTRL2 Basic UDI-DIDate13 Mar 2026RegisteredStatusActive

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  • Withdrawn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, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Diamond Phaco Knife Angled - Spear Shaped 13 cm - 5" Blade Width 3.2 mm Titanium Handle EUDAMED
Surtex GUDID
Generic Name
Ophthalmic knife, reusable
Device Name
Cutting Instruments
Surgical knives, reusable
Model / Reference
OP-341-32, 50554459SCPLANDKIRL0102EB
Primary DI / UDI-DI
05056111301586
Basic UDI-DI
50554459CUTTINGINSTRL2, B-05056111301586
FDA Product Code
EMF
EMDN Code
L0102 Surgical knives, reusable
GMDN Term
Ophthalmic knife, reusable
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Spain
GUDID distribution status
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

  • 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