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TruFire™ Suture Passer with Non-Ratcheting Handle

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

Ref 382100cnModel TruFire™ Suture Passer

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
European UnionCE/MDR EUDAMED Number81012846TruFireREDT Basic UDI-DI 10810128460610UDI-DIDate25 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number10810128460610 UDI-DI Date29 Oct 2024ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TruFire™ Suture Passer with Non-Ratcheting Handle EUDAMED
TruFire™ GUDID
Generic Name
Suturing unit, reusable
Device Name
TruFire™ Suture Passer with Ratcheting Handle
Model / Ref / Catalog
TruFire™ Suture Passer, 382100cn, TF-SPNR
Primary DI / UDI-DI
10810128460610
Basic UDI-DI
81012846TruFireREDT
Direct Marketing DI
10810128460610
FDA Product Code
LXH
EMDN Code
H9099 Suture devices - other
GMDN Term
Suturing unit, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
TruFire™ Suture Passer
382100cn
GUDID
TF-SPNR

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

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No