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Biomol

by H.S. Hospital Service SpA 7 variants

Ref BM 1609Model BIOMOL

Biomol (BM 1609) 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-08033003340554), cleared under FDA 510(k) K002947 on 19 Dec 2000 and listed in FDA GUDID since 22 Sep 2021 (UDI-DI 08033003340554), active as of 8 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 8 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 8 Oct 2026.

Regulatory status

as of registry sync 8 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033003340554 Basic UDI-DI 08033003340554UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033003340554 UDI-DI Date22 Sep 2021ListedStatusListed 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-08033003340554 registered 18 Aug 2026 Active
  • FDA 510(k) K002947 decided 19 Dec 2000 Active
  • FDA GUDID UDI-DI 08033003340554 listed 22 Sep 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K002947
  2. Listed FDA GUDID 08033003340554
  3. Registered EUDAMED B-08033003340554

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  • Withdrawn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 1609
Primary DI / UDI-DI
08033003340554
Basic UDI-DI
B-08033003340554
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
Needle Gauge — 16 Gauge
Length — 90 Millimeter

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)