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PALAMIX® Cement gun

by Heraeus Medical LLC

Ref 66036163

PALAMIX® Cement gun (66036163) is a Class I device made by Heraeus Medical LLC, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 42601021304060001KD) and listed in FDA GUDID since 19 Mar 2018 (UDI-DI 04260102131170), active as of 9 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42601021304060001KD Basic UDI-DI 04260102131170UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260102131170 UDI-DI Date19 Mar 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42601021304060001KD registered 2 Jul 2026 Active
  • FDA GUDID UDI-DI 04260102131170 listed 19 Mar 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260102131170
  2. Registered EUDAMED 42601021304060001KD

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  • Withdrawn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
PALAMIX cement gun EUDAMED
Palamix® GUDID
Generic name
Orthopaedic implantable material dispenser, cartridge-/syringe-accepting, reusable
Model / Ref / Catalog
66036163, Cement gun
Primary DI / UDI-DI
04260102131170
Basic UDI-DI
42601021304060001KD
FDA product code
KIH
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Orthopaedic implantable material dispenser, cartridge-/syringe-accepting, reusable
Device class
Class I
Regulation number
888.4200
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
66036163
GUDID
Cement gun

Related devices

Category: Orthopaedic cement dispenser

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

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (21, all answered No)