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Direct Drive Reposable Graspers C4121

by Applied Medical Resources Corp.

Ref C4121Model Epix® Laparoscopic Graspers

Direct Drive Reposable Graspers C4121 is a device classified as Class IIa in the EU and Class I in the US made by Applied Medical Resources Corp., registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 0607915IIA035G7) and listed in FDA GUDID since 30 Aug 2016 (UDI-DI 00607915116873), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0607915IIA035G7 Basic UDI-DI 00607915116873UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00607915116873 UDI-DI Date30 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0607915IIA035G7 registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 00607915116873 listed 30 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00607915116873
  2. Registered EUDAMED 0607915IIA035G7

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  • Withdrawn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
Epix Laparoscopic Graspers EUDAMED
Direct Drive Reposable Graspers GUDID
Generic name
Rigid endoscopic tissue manipulation forceps, single-use
Device name
Epix® Laparoscopic Graspers
Model / reference
C4121, Epix® Laparoscopic Graspers
Primary DI / UDI-DI
00607915116873
Basic UDI-DI
0607915IIA035G7
FDA product code
NWV
EMDN code
K01020103 Minimally invasive surgery manipulators, single-use
GMDN term
Rigid endoscopic tissue manipulation forceps, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
884.1720
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 5 Millimeter
Length — 45 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Rigid endoscopic tissue manipulation forceps, single-use

Similar devices in this category

Other devices filed under MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENTS, SINGLE-USE.

Other devices from Applied Medical Resources Corp.

See all devices from Applied Medical Resources Corp. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)