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Automatic Disposable Biopsy Needle

by Canyon Medical Inc. 226 variants

Ref BN-1/141822-2Model BN-1/121011

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Overview

The Automatic Disposable Biopsy Needle is a highly advanced medical device designed to streamline biopsies, improving patient outcomes and reducing procedural time. With its unique disposable technology, this device ensures the highest level of sterility and safety for both patients and healthcare professionals.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6954414600300001F7 Basic UDI-DI 06954414662054UDI-DIDate12 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06954414662054 UDI-DI Date19 Jun 2023ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Automatic Disposable Biopsy Needle EUDAMED
SureCore Automatic Disposable Biopsy Needle GUDID
Generic Name
Soft-tissue biopsy procedure kit, non-medicated
Model / Reference
BN-1/121011, BN-1/141822-2
Primary DI / UDI-DI
06954414662054
Basic UDI-DI
6954414600300001F7, B-06954414662054
510(k) Number
FDA Product Code
KNW
EMDN Code
A0102010101 Shearing biopsy needles
GMDN Term
Soft-tissue biopsy procedure kit, non-medicated
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000022663
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Canyon Medical Inc.

See all devices from Canyon Medical Inc. →

Properties

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

Other properties (18)

  • 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