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Pro Nozzle medium 66054436

by Heraeus Medical LLC

Ref 66054436_Legacy

Pro Nozzle medium 66054436 is a device classified as Class IIa in the EU and Class I in the US made by Heraeus Medical LLC, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI B-04260102133051) and listed in FDA GUDID since 26 Apr 2019 (UDI-DI 04260102133051), active as of 9 Nov 2026.

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

CE MDD

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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04260102133051 Basic UDI-DI 04260102133051UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260102133051 UDI-DI Date26 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04260102133051 registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 04260102133051 listed 26 Apr 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260102133051
  2. Registered EUDAMED B-04260102133051

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Pro Nozzle medium
Generic name
Noninvasive manual orthopaedic cement preparation kit, reusable
Model / reference
66054436_Legacy EUDAMED
66054436 GUDID
Primary DI / UDI-DI
04260102133051
Basic UDI-DI
B-04260102133051
FDA product code
KIH
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Noninvasive manual orthopaedic cement preparation kit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4200
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
66054436_Legacy
GUDID
66054436
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: Manual orthopaedic cement mixer, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS.

Other devices from Heraeus Medical LLC

See all devices from Heraeus Medical LLC →

Properties

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