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Achieve® 10884450443696

by Merit Medical Systems, Inc.

Ref A1411/BModel Corvocet Biopsy System, Achieve Biopsy System, Pink Achieve Biopsy System

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

CE MDD

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450443699 Basic UDI-DI 00884450443699UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450443699 UDI-DI Date13 May 2020ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Achieve®
Generic name
Soft-tissue biopsy procedure kit, non-medicated
Device name
Automatic Biopsy System
Model / Ref / Catalog
Corvocet Biopsy System, Achieve Biopsy System, Pink Achieve Biopsy System, A1411/B, 10884450443696
Primary DI / UDI-DI
00884450443699 EUDAMED
10884450443696 GUDID
Basic UDI-DI
B-00884450443699
FDA product code
KNW
EMDN code
A010299 Biopsy needles and kits - other
GMDN term
Soft-tissue biopsy procedure kit, non-medicated
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Corvocet Biopsy System, Achieve Biopsy System, Pink Achieve Biopsy System
A1411/B
GUDID
10884450443696
Primary DI / UDI-DIEUDAMED
00884450443699
GUDID
10884450443696
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Soft-tissue biopsy procedure kit, non-medicated

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (17)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No