Skip to content

Activa Instrument

by Bioretec Ltd. 45 variants

Ref B-DIP-2000

Activa Instrument (B-DIP-2000) is a device classified as Class IIa in the EU and Class II in the US made by Bioretec Ltd., registered in EUDAMED on 2 Dec 2021 (Basic UDI-DI B-06438394002326), cleared under FDA 510(k) K080879 on 24 Jun 2008 and listed in FDA GUDID since 5 Feb 2026 (UDI-DI 06438394002326), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K080879

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06438394002326 UDI-DI Date5 Feb 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06438394002326 Basic UDI-DI 06438394002326UDI-DIDate2 Dec 2021RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK080879 Date24 Jun 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06438394002326 registered 2 Dec 2021 Active
  • FDA 510(k) K080879 decided 24 Jun 2008 Active
  • FDA GUDID UDI-DI 06438394002326 listed 5 Feb 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K080879
  2. Registered EUDAMED B-06438394002326
  3. Listed FDA GUDID 06438394002326

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  • Withdrawn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

Trade name
Activa Instrument EUDAMED
Disposable Pin Applicator GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
B-DIP-2000
Primary DI / UDI-DI
06438394002326
Basic UDI-DI
B-06438394002326
510(k) Number
FDA product code
HTY
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
Size
Width — 2.0 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.

Manufacturer details

EUDAMED SRN
FI-MF-000001328

Related devices

Category: Joint prosthesis implantation kit, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Bioretec Ltd.

See all devices from Bioretec Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)