Identity
- Trade Name
- Ennovate® EUDAMED
- Device Name
- ENNOVATE implant, sterile EUDAMED
- Model / Reference
- SY480KS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046955204496 EUDAMED
- Basic UDI-DI
- 40392390000012962P EUDAMED
- EMDN Code
- P09070304 SPINE FIXATION SYSTEM CONNECTORS 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
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
Category: Bone-screw internal spinal fixation system connector
Ennovate® by Aesculap AG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 40392390000012962P | Class IIb | Active |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (1)
- EUDAMED f7940741-a5a2-4751-a2d1-4350a4ea4433 61 fields · synced Jun 19, 2026