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Cement Pressurizer Prz-01

by Tecres

Ref PRZ-01

Cement Pressurizer Prz-01 is a device classified as Class IIa in the EU and Class I in the US made by Tecres, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 80314970627PG) and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 08031497002248), 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 Number80314970627PG Basic UDI-DI 08031497002248UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08031497002248 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80314970627PG registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 08031497002248 listed 23 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08031497002248
  2. Registered EUDAMED 80314970627PG

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  • Withdrawn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
Cement Pressurizer
Generic name
Orthopaedic cement compressor
Model / reference
PRZ-01
Primary DI / UDI-DI
08031497002248
Basic UDI-DI
80314970627PG
FDA product code
LXH
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Orthopaedic cement compressor
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Portugal
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: Orthopaedic cement compressor

Similar devices in this category

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

Other devices from Tecres

See all devices from Tecres →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)