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SpaceFlex Shoulder Instrument Kit

by G21 S.R.L. Italy EUDAMEDGUDID

Ref 900012Model 900008

Product code MBBEMDN P09010403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08058964726797 UDI-DIDate16 Oct 2024ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number0805896472spaceflexHE Basic UDI-DIDate25 Nov 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
Orthopaedic cement spacer mould
Device Name
SpaceFlex Hip Instrument Kit
SpaceFlex Instrument Kit
Model / Reference
900008, 900012
Primary DI / UDI-DI
08058964726797
Basic UDI-DI
0805896472spaceflexHE, 805896472instrumentU4
Direct Marketing DI
08058964726797
510(k) Number
FDA Product Code
MBB, HSD, KWS
EMDN Code
P09010403 Shoulder prostheses spacers
GMDN Term
Orthopaedic cement spacer mould
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3027, 888.3690, 888.3660
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
IT-MF-000030085

Properties & raw data

Show properties, registry sources and raw records
  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Reusable NoEUDAMEDYesEUDAMED
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED f2f417bb-a394-40a2-b68e-266dbfb9d958 61 fields · synced 22 Oct 2026
  • FDA UDI ff54f797-aec3-485c-b41f-aea71e68b924 33 fields · synced 30 May 2026
  • EUDAMED 08058964726797|805896472INSTRUMENTU4 61 fields · synced 24 Oct 2026