Identity
- Trade Name
- TSPACE 3D EUDAMED
- Device Name
- PROSPACE/TSPACE implantation instr. I EUDAMED
- Model / Reference
- SN704R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046955315758 EUDAMED
- Basic UDI-DI
- 40392390000006162C EUDAMED
- Direct Marketing DI
- 04046955315758 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
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
Tspace 3d by Aesculap AG — Class I — 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 | 40392390000006162C | Class I | Active |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (1)
- EUDAMED b3057915-9d9d-410d-a298-33a77b9353f0 61 fields · synced Jun 19, 2026