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Rocket R54549-32-PK

by Rocket Medical Plc

Ref R54549-32-PK

Rocket R54549-32-PK is a device classified as Class IIa in the EU and Class I in the US made by Rocket Medical Plc, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 50552709PP38AFS) and listed in FDA GUDID since 23 Oct 2023 (UDI-DI 05055270983268), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number50552709PP38AFS Basic UDI-DI 05055270983268UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055270983268 UDI-DI Date23 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 50552709PP38AFS registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 05055270983268 listed 23 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055270983268
  2. Registered EUDAMED 50552709PP38AFS

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Rocket 32Fg Chest Catheter - Blunt Dissection Chest Drainage Insertion Pack EUDAMED
Rocket GUDID
Generic name
Incision/drainage kit
Device name
TF_R038 PP Blunt Dissection
Model / Ref / Catalog
R54549-32-PK
Primary DI / UDI-DI
05055270983268
Basic UDI-DI
50552709PP38AFS
FDA product code
GBX
EMDN code
A0601010401 Thoracic drainages (straight and angled)
GMDN term
Incision/drainage kit
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4200
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 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: Incision/drainage kit

Similar devices in this category

Other devices filed under THORACIC DRAINAGES (STRAIGHT AND ANGLED).

Other devices from Rocket Medical Plc

See all devices from Rocket Medical Plc →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)