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ReNew 3301

by Microline Surgical, Inc.

Ref 3301

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

CE MDR

Valid until

6 Sep 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3841767CE01 Date6 Sep 2026IssuedStatusActive expires 6 Sep 2031
United StatesGUDID listing GUDID Number00811099014119 UDI-DI Date13 Nov 2017ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3841767CE01 Active Reissued

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    6 Sep 2026
    Expires
    6 Sep 2031

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  • Withdrawn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
ReNew Babcock Grasper Tip, 5mm EUDAMED
ReNew GUDID
Generic name
Rigid endoscopic tissue manipulation forceps, reusable
Device name
ReNew Reusable Tips
Model / Ref / Catalog
3301
Primary DI / UDI-DI
00811099014119 EUDAMED
00811099011859 GUDID
Basic UDI-DI
081109901DOC005SD
Direct marketing DI
00811099014119
FDA product code
GEI
EMDN code
L1204 Laparoscopic and thoracoscopic surgery forceps, reusable
GMDN term
Rigid endoscopic tissue manipulation forceps, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00811099014119
GUDID
00811099011859
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Rigid endoscopic tissue manipulation forceps, reusable

Other devices from Microline Surgical, Inc.

  • ReNew 3412

    Class II

  • ReNew 3362

    Class II

  • ReNew 3946

    Class II

  • ReNew 3411

    Class II

  • Microline 132-135D

    Class II

  • ReNew 3322

    Class II

See all devices from Microline Surgical, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (20)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No