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Mb Set

by H.S. Hospital Service SpA 2 variants

Ref MB 2207Model MB SET

Mb Set (MB 2207) is a device classified as Class IIa in the EU and Class I in the US made by H.S. Hospital Service SpA, registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI B-08033003344682) and listed in FDA GUDID since 9 Jan 2025 (UDI-DI 08033003344682), active as of 25 Oct 2026.

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033003344682 Basic UDI-DI 08033003344682UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033003344682 UDI-DI Date9 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08033003344682 registered 21 Aug 2026 Active
  • FDA GUDID UDI-DI 08033003344682 listed 9 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033003344682
  2. Registered EUDAMED B-08033003344682

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  • Withdrawn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

Generic name
Cell-block cytology aspiration needle
Model / Ref / Catalog
MB SET, MB 2207
Primary DI / UDI-DI
08033003344682
Basic UDI-DI
B-08033003344682
FDA product code
GAA
EMDN code
A01020102 Aspiration fine needles and kits
GMDN term
Cell-block cytology aspiration needle
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
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 — 22 Gauge
Length — 70 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Cell-block cytology aspiration needle

Similar devices in this category

Other devices filed under ASPIRATION FINE NEEDLES AND KITS.

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
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)