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Biomol

by H.S. Hospital Service SpA 7 variants

Ref BM 2010Model BIOMOL

Biomol (BM 2010) is a device classified as Class IIa in the EU and Class II in the US made by H.S. Hospital Service SpA, registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI B-08033003340707), cleared under FDA 510(k) K002947 on 19 Dec 2000 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 08033003340707), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K002947

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033003340707 Basic UDI-DI 08033003340707UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033003340707 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK002947 Date19 Dec 2000DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033003340707 registered 18 Aug 2026 Active
  • FDA 510(k) K002947 decided 19 Dec 2000 Active
  • FDA GUDID UDI-DI 08033003340707 listed 26 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K002947
  2. Listed FDA GUDID 08033003340707
  3. Registered EUDAMED B-08033003340707

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Body aspiration needle, single-use
Model / Ref / Catalog
BIOMOL, BM 2010
Primary DI / UDI-DI
08033003340707
Basic UDI-DI
B-08033003340707
510(k) Number
FDA product code
FCG
EMDN code
A0102010101 Shearing biopsy needles
GMDN term
Body aspiration needle, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 100 Millimeter
Needle Gauge — 20 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Body aspiration needle, single-use

Cleared under the same submission (K002947)

and 5 more cleared under K002947

Similar devices in this category

Other devices filed under NEEDLES.

Other devices from H.S. Hospital Service SpA

  • Trap Easy

    Class II

  • Ecojekt

    Class I

  • Bmn I Type

    Class II

  • Introducer Needle

    Class I

See all devices from H.S. Hospital Service SpA →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)