← Back to catalogue
NiTiBOND®
EUDAMEDClass IIb (EU MDR)
Ref 1007103Model Stapedioplasty prosthesisRef 1007153Ref 1007105Ref 1007155Ref 1007106Ref 1007111Ref 1007158Ref 1007109Ref 1007154Ref 1007156
Identity
- Trade Name
- NiTiBOND® EUDAMED
- Device Name
- NiTiBOND EUDAMED
- Model / Reference
- Stapedioplasty prosthesis EUDAMED1007103 EUDAMED1007153 EUDAMED1007105 EUDAMED1007155 EUDAMED1007106 EUDAMED1007111 EUDAMED1007158 EUDAMED1007109 EUDAMED1007154 EUDAMED1007156 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368832000 EUDAMED14250368832109 EUDAMED14250368832024 EUDAMED14250368832123 EUDAMED14250368832031 EUDAMED14250368832086 EUDAMED14250368832154 EUDAMED14250368832062 EUDAMED14250368832116 EUDAMED14250368832130 EUDAMED
- Basic UDI-DI
- B-14250368832000 EUDAMEDB-14250368832109 EUDAMEDB-14250368832024 EUDAMEDB-14250368832123 EUDAMEDB-14250368832031 EUDAMEDB-14250368832086 EUDAMEDB-14250368832154 EUDAMEDB-14250368832062 EUDAMEDB-14250368832116 EUDAMEDB-14250368832130 EUDAMED
- EMDN Code
- P02010102 STAPEDIOPLASTIC PROSTHESES 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
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
NiTiBOND® by Heinz Kurz GmbH — Class IIb — 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-14250368832000 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (10)
- EUDAMED 83a62be1-4bd0-4d47-bb9c-56d4e4d1a487 61 fields · synced Oct 7, 2026
- EUDAMED a4584d21-e571-4aa2-8747-59c211784222 61 fields · synced May 17, 2026
- EUDAMED 4b852351-6bbd-4926-9bb7-168955cb2da4 61 fields · synced May 17, 2026
- EUDAMED 71e0076d-b46c-4fea-b279-17ae8cdd088c 61 fields · synced May 17, 2026
- EUDAMED 2183a344-7a16-4cf2-8f7e-97f173068eac 61 fields · synced May 17, 2026
- EUDAMED 9acad9c5-3ac3-4827-a133-6f091360c2a7 61 fields · synced May 18, 2026
- EUDAMED 44495af4-aa32-4959-b035-49a3b7b28401 61 fields · synced May 18, 2026
- EUDAMED 0dcda94a-45d0-478d-bf88-bd366e94c7f5 61 fields · synced May 18, 2026
- EUDAMED e4b5479d-6a1a-40e4-8b22-480acda99a99 61 fields · synced Jul 10, 2026
- EUDAMED 26895045-7980-4cb4-b46c-cc68fa9b0bec 61 fields · synced Jul 17, 2026