Identity
- Trade Name
- NovaBone Putty EUDAMED
- Device Name
- NovaBone Putty EUDAMED
- Model / Reference
- 770605 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813909010045 EUDAMED
- Basic UDI-DI
- B-00813909010045 EUDAMED
- EMDN Code
- P900401 BONE AND TENDON REPLACEMENT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NovaBone Putty by NovaBone Products, LLC — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813909010045 | Class III | Active |
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Manufacturer
- Manufacturer
- NovaBone Products, LLC
- EUDAMED SRN
- US-MF-000020624
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 7c17d84d-6fb9-48db-9c96-9d354b628a57 61 fields · synced Jun 9, 2026