Identity
- Trade Name
- S4® EUDAMED
- Device Name
- S4_S4E implant, sterile EUDAMED
- Model / Reference
- ST496T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046964534096 EUDAMED
- Basic UDI-DI
- 40392390000026993Q EUDAMED
- EMDN Code
- P09070399 IMPLANTABLE SPINAL STABILISATION OR FIXATION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
S4® by Aesculap AG — Class IIb — 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 | 40392390000026993Q | Class IIb | Active |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (1)
- EUDAMED 577adc67-21a2-44d3-b829-265994d7c224 61 fields · synced Aug 1, 2026