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Pac

by Sterylab SRL

Ref PAC102030

Pac (PAC102030) is a device classified as Class I in the EU and Class II in the US made by Sterylab SRL, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 803395922PAC102030J6), cleared under FDA 510(k) K051506 on 27 Jul 2005 and listed in FDA GUDID since 3 Oct 2019 (UDI-DI 08033959221990), active as of 7 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K051506

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803395922PAC102030J6 Basic UDI-DI 08033959221990UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033959221990 UDI-DI Date3 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK051506 Date27 Jul 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803395922PAC102030J6 registered 28 Oct 2026 Active
  • FDA 510(k) K051506 decided 27 Jul 2005 Active
  • FDA GUDID UDI-DI 08033959221990 listed 3 Oct 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K051506
  2. Listed FDA GUDID 08033959221990
  3. Registered EUDAMED 803395922PAC102030J6

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Biopsy gun handpiece, mechanical
Device name
Pistola per aspirazione
Model / Ref / Catalog
PAC102030, PAC
Primary DI / UDI-DI
08033959221990
Basic UDI-DI
803395922PAC102030J6
510(k) Number
FDA product code
FCG, KNW
EMDN code
A0280 Syringes - accessories
GMDN term
Biopsy gun handpiece, mechanical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PAC102030
GUDID
PAC
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08033959221990: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class I 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: Biopsy gun handpiece, mechanical

Cleared under the same submission (K051506)

and 8 more cleared under K051506

Similar devices in this category

Other devices filed under SYRINGES - ACCESSORIES.

Other devices from Sterylab SRL

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    Class II

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See all devices from Sterylab SRL →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)