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InSpace™ system

by Ortho-Space Ltd 2 variants

Ref 0127Model Small

InSpace™ system (0127) is a Class III device made by Ortho-Space Ltd, registered in EUDAMED on 6 Sep 2024 (Basic UDI-DI 7290013396010WW) with CE/MDR certificate 3903006CE01 valid until 1 Feb 2028, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7290013396010WW Basic UDI-DI 17290013396010UDI-DIDate6 Sep 2024RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 3903006CE01 Cancelled

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    8 Jan 2024
    Expires
    1 Feb 2028
    Reason
    Other
  • 3903006TD01 Cancelled

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    8 Jan 2024
    Expires
    1 Feb 2028
    Reason
    Other

Timeline

5 dated events

  1. Certificate issued EUDAMED 3903006CE01
  2. Certificate issued EUDAMED 3903006TD01
  3. Registered EUDAMED 7290013396010WW
  4. Certificate expires EUDAMED 3903006CE01
  5. Certificate expires EUDAMED 3903006TD01

Coverage

1 jurisdiction

Germany
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Germany since 28 Feb 2025

Last checked 24 Oct 2026.

Specification

EUDAMED

Device name
InSpace™ system
Model / reference
Small, 0127
Primary DI / UDI-DI
17290013396010
Basic UDI-DI
7290013396010WW
EMDN code
P900402 Resorbable filling and reconstruction devices
Device class
Class III
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000018637
Authorised representative
CEpartner4U NL-AR-000000111

Similar devices in this category

Other devices filed under RESORBABLE FILLING AND RECONSTRUCTION DEVICES.

Other devices from Ortho-Space Ltd

See all devices from Ortho-Space Ltd →

Properties

  • Supplied sterile
  • Implantable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
Other properties (11, all answered No)