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Rocket R54400-00-00

by Rocket Medical Plc

Ref R54400-00-00

Rocket R54400-00-00 is a device classified as Class I in the EU and Class II in the US made by Rocket Medical Plc, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 50552709PP15CFB), cleared under FDA 510(k) K123033 on 1 Feb 2013 and listed in FDA GUDID since 20 Oct 2023 (UDI-DI 05055270982339), 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) K123033

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 Number50552709PP15CFB Basic UDI-DI 05055270982339UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055270982339 UDI-DI Date20 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123033 Date1 Feb 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 50552709PP15CFB registered 28 Oct 2026 Active
  • FDA 510(k) K123033 decided 1 Feb 2013 Active
  • FDA GUDID UDI-DI 05055270982339 listed 20 Oct 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K123033
  2. Listed FDA GUDID 05055270982339
  3. Registered EUDAMED 50552709PP15CFB

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  • Withdrawn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

Trade name
Rocket IPC Dressing Pack EUDAMED
Rocket GUDID
Generic name
Pleural/peritoneal drainage catheterization kit, non-medicated
Device name
TF_R015 PP IPC Dressing
Model / Ref / Catalog
R54400-00-00
Primary DI / UDI-DI
05055270982339
Basic UDI-DI
50552709PP15CFB
510(k) Number
FDA product code
DWM
EMDN code
A0680 Drainage and fluid collection devices - accessories
GMDN term
Pleural/peritoneal drainage catheterization kit, non-medicated
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.5050
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
The procedure pack is intended to combine devices which have their own individual intended purposes.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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: Pleural/peritoneal drainage catheterization kit

Cleared under the same submission (K123033)

and 8 more cleared under K123033

Similar devices in this category

Other devices filed under DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES.

Other devices from Rocket Medical Plc

See all devices from Rocket Medical Plc →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)