Identity
- Trade Name
- Ennovate® EUDAMEDENNOVATE C FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- ENNOVATE C instrument IIa SU sterile EUDAMEDENNOVATE C OC/AC BIT SET F/SCREW-D4.5MM FDA UDI
- Model / Reference
- SZ120SU EUDAMEDFDA UDI
- Description
- ENNOVATE C OC/AC BIT SET F/SCREW-D4.5MM FDA UDI
Identifiers
- Catalog Number
- SZ120SU FDA UDI
- Primary DI / UDI-DI
- 04046955186389 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000026252T EUDAMED
- FDA Product Code
- NKG FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3075 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Joint prosthesis implantation kit, single-use
Ennovate® by Aesculap AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40392390000026252T | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 8750b666-a3ce-4e41-b3d6-9f6257675862 61 fields · synced Jun 18, 2026
- FDA UDI e8762425-96f5-4165-aa83-6211b63f7e31 35 fields · synced May 30, 2026