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Sternobell

by Biopsybell SRL 15 variants

Ref RN1340

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberIT349638 Date10 Feb 2026IssuedStatusWithdrawn expires 9 Feb 2030 withdrawn 15 Jun 2026
European UnionCE/MDD EUDAMED Number8033860BIOEFT01U5 Basic UDI-DI 08033860042875UDI-DIDate20 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033860042875 UDI-DI Date29 Aug 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  • Withdrawn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/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Sternobell EUDAMED
Biopsybell SRL GUDID
Generic Name
Bone marrow biopsy procedure kit
Device Name
Needles for Biopsy or Explant
Model / Ref / Catalog
RN1340, STERNOBELL
Primary DI / UDI-DI
08033860042875
Basic UDI-DI
8033860BIOEFT01U5, B-08033860042875
510(k) Number
FDA Product Code
FCG, KNW
EMDN Code
A01020201 Iliac-sternal biopsy needles and kits
GMDN Term
Bone marrow biopsy procedure kit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 13 Gauge
Length — 40 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
RN1340
GUDID
STERNOBELL
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