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Double X K-Wire Eye Speculum Adjustable Opening Blade Size 15 mm Stainless Steel

by Surtex Instruments Ltd

Ref OP-089-15Model 50554459SPECULASI1701027K

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

CE MDR

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 Number05056111337776 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number50554459SPECULAS96 Basic UDI-DI 05056111337776UDI-DIDate15 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Double X K-Wire Eye Speculum Adjustable Opening Blade Size 15 mm Stainless Steel EUDAMED
Surtex GUDID
Generic Name
Eyelid speculum, reusable
Device Name
Specula
Ocular and endocular retractors, reusable
Model / Reference
OP-089-15, 50554459SPECULASI1701027K
Primary DI / UDI-DI
05056111337776
Basic UDI-DI
50554459SPECULAS96, 50554459SPECULASI1701027K
FDA Product Code
HNC
EMDN Code
L170102 Ocular and endocular retractors, reusable
GMDN Term
Eyelid speculum, reusable
Device Class
Class I
Regulation Number
886.4350
EU 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 YesEUDAMEDNoEUDAMED
  • 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