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UltraGrip TC Stratte Needle Holder 27 cm - 10 3/4" Stainless Steel

by Surtex Instruments Ltd

Ref SU-615-27Model 50554459WIRESUTUIRL0205YD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05056111339145 Basic UDI-DI 05056111339145UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056111339145 UDI-DI Date12 May 2026ListedStatusListed 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  • Withdrawn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

Trade Name
UltraGrip TC Stratte Needle Holder 27 cm - 10 3/4" Stainless Steel EUDAMED
Surtex GUDID
Generic Name
Suturing needle holder, reusable
Device Name
Needle holders, reusable
Model / Reference
50554459WIRESUTUIRL0205YD, SU-615-27
Primary DI / UDI-DI
05056111339145
Basic UDI-DI
B-05056111339145
FDA Product Code
FHQ
EMDN Code
L0205 Needle holders, reusable
GMDN Term
Suturing needle holder, reusable
Device Class
Class I
Regulation Number
876.4730
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
  • 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