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Ester

by Biopsybell SRL 15 variants

Ref GUN1620EC

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

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

Documents

1 certificate

Certifier BUREAU VERITAS ITALIA S.P.A.

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 NumberB-08033860003166 Basic UDI-DI 08033860003166UDI-DIDate20 May 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08033860003166 Basic UDI-DI 08033860003166UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033860003166 UDI-DI Date20 Jun 2023ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

2 recalls · FDA

    • Terminated Z-1700-2021 FDA Class II initiated 25 Mar 2021 on shared 510(k) K130616

    Products distributed as sterile may not have been adequately sterilized

    • Terminated Z-1634-2021 FDA Class II initiated 22 Mar 2021

    Products labeled as sterile were distributed, but may not have been sterilized.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ester EUDAMED
Biopsybell GUDID
Generic Name
End-cut biopsy gun handpiece/needle
Device Name
Needles for Biopsy or Explant
Soft Tissues Biopsy Needles (Semiautomatic and Automatic)
Model / Ref / Catalog
GUN1620EC, ESTER
Primary DI / UDI-DI
08033860003166
Basic UDI-DI
B-08033860003166, 8033860BIOEFT01U5, 8033860BIOAFT01SR
510(k) Number
FDA Product Code
FCG, KNW
EMDN Code
A0102010102 Shearing biopsy guns
GMDN Term
End-cut biopsy gun handpiece/needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Length — 150 Millimeter
Needle Gauge — 14 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
GUN1620EC
GUDID
ESTER
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000011601

Other devices from Biopsybell SRL

See all devices from Biopsybell SRL →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No