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Champion+ Suture Passer Needle (5/box) 3910-600-003

by T.A.G Medical Products Agricultural Cooperative Association

Ref 382200stModel SINGLE-USE INSTRUMENTS FOR SUTURES

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number81012846CHAMPIONSLIDSYS2N Basic UDI-DI 10810128463017UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10810128463017 UDI-DI Date14 Jun 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Champion+ Suture Passer Needle (5/box)
Generic Name
Suturing unit, single-use
Model / Ref / Catalog
SINGLE-USE INSTRUMENTS FOR SUTURES, 382200st, 3910-600-003
Primary DI / UDI-DI
10810128463017
Basic UDI-DI
81012846CHAMPIONSLIDSYS2N
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SINGLE-USE INSTRUMENTS FOR SUTURES
382200st
GUDID
3910-600-003
Device ClassEUDAMED
Class IIa
GUDID
Class I
Contains LatexEUDAMED
No
GUDID
Yes

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Properties

  • Sterile
  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: 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
  • Serial Number: No