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Brainpro 41778C

by Pajunk GmbH Medizintechnologie

Ref 41778CModel BrainPro

Brainpro 41778C is a device classified as Class III in the EU and Class II in the US made by Pajunk GmbH Medizintechnologie, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-04048223098981), cleared under FDA 510(k) K060808 on 25 Jul 2006 and listed in FDA GUDID since 2 Apr 2021 (UDI-DI 04048223098981), 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) K060808

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-04048223098981 Basic UDI-DI 04048223098981UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048223098981 UDI-DI Date2 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK060808 Date25 Jul 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04048223098981 registered 16 Oct 2026 Active
  • FDA 510(k) K060808 decided 25 Jul 2006 Active
  • FDA GUDID UDI-DI 04048223098981 listed 2 Apr 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K060808
  2. Listed FDA GUDID 04048223098981
  3. Registered EUDAMED B-04048223098981

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  • Withdrawn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
Brainpro
Generic name
Brain biopsy procedure kit
Model / Ref / Catalog
41778C, BrainPro
Primary DI / UDI-DI
04048223098981
Basic UDI-DI
B-04048223098981
510(k) Number
FDA product code
HAW
EMDN code
A010299 Biopsy needles and kits - other
GMDN term
Brain biopsy procedure kit
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Brain biopsy procedure kit

Cleared under the same submission (K060808)

Similar devices in this category

Other devices filed under BIOPSY NEEDLES AND KITS - OTHER.

Other devices from Pajunk GmbH Medizintechnologie

See all devices from Pajunk GmbH Medizintechnologie →

Properties

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