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Mediflex D4001

by Endosys Healthcare India Private Limited

Ref MSG-BT-A / D4001

Mediflex D4001 is a wire/ligature passer (EU MDR Class IIa; FDA Class I) made by Endosys Healthcare India Private Limited, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 089043326MSG00177) and listed in FDA GUDID since 19 May 2025 (UDI-DI 08904332600766), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number089043326MSG00177 Basic UDI-DI 08904332600766UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08904332600766 UDI-DI Date19 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 089043326MSG00177 registered 27 May 2026 Active
  • FDA GUDID UDI-DI 08904332600766 listed 19 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08904332600766
  2. Registered EUDAMED 089043326MSG00177

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  • Withdrawn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
SureGrip EUDAMED
Mediflex GUDID
Generic name
Wire/ligature passer, single-use
Device name
Multipurpose Suture Grasper / Suture Grasper
Model / Ref / Catalog
MSG-BT-A / D4001 EUDAMED
D4001 GUDID
Primary DI / UDI-DI
08904332600766
Basic UDI-DI
089043326MSG00177
FDA product code
HCF, GCJ
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
GMDN term
Wire/ligature passer, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800, 876.1500
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MSG-BT-A / D4001
GUDID
D4001
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Wire/ligature passer, single-use

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER.

Other devices from Endosys Healthcare India Private Limited

See all devices from Endosys Healthcare India Private Limited →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)