← Back to catalogue
InSpace™ system
EUDAMEDClass III (EU MDR)
Ref 0129Model LargeRef 0128Model Medium
Identity
- Device Name
- InSpace™ system EUDAMED
- Model / Reference
- Large EUDAMED0129 EUDAMEDMedium EUDAMED0128 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290013396034 EUDAMED17290013396027 EUDAMED
- Basic UDI-DI
- 7290013396034XC EUDAMED7290013396027XF EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
InSpace™ system by Ortho-Space Ltd — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7290013396034XC | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho-Space Ltd
- EUDAMED SRN
- IL-MF-000018637
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 9afd6afd-9ce7-41f7-b896-14efb4ac798c 61 fields · synced Jul 16, 2026
- EUDAMED 10f3a730-42d4-48b8-a914-a84085e08556 61 fields · synced Jul 16, 2026