Identity
- Device Name
- Bone Filler EUDAMED
- Model / Reference
- 1006020603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250539902283 EUDAMED
- Basic UDI-DI
- B-04250539902283 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bone Filler by HumanTech Spine GmbH — Class IIa — 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-04250539902283 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HumanTech Spine GmbH
- EUDAMED SRN
- DE-MF-000010596
Sources (1)
- EUDAMED e5032850-cda8-4865-aa4e-ddeaacff7bc6 61 fields · synced Jul 13, 2026