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CapsuleStitch™ Suture Passer

by T.A.G. Medical products corporation LTD. EUDAMEDGUDID

Active European Union

Ref 255001arModel Suture Passer

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number81012846DragonTongueSut7U Basic UDI-DIDate29 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number10818674027431 UDI-DIDate5 Jan 2023ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
CapsuleStitch™ Suture Passer EUDAMED
Ambush Suture Passer GUDID
Generic Name
Suturing unit, single-use
Device Name
Dragon Tongue Suture Passer 70 Up
Model / Ref / Catalog
Suture Passer EUDAMED
255001ar EUDAMED
A GUDID
255001t GUDID
Primary DI / UDI-DI
10818674027431
Basic UDI-DI
81012846DragonTongueSut7U
Direct Marketing DI
10818674027431
FDA Product Code
LXH
EMDN Code
H900899 Single-use instruments for sutures - other
GMDN Term
Suturing unit, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Suture Passer
255001ar
GUDID
A
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IL-MF-000029151
Authorised representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Other devices from T.A.G. Medical products corporation LTD.

See all devices from T.A.G. Medical products corporation LTD. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: 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
  • Manufacturing Date: No