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NiTiFLEX
EUDAMEDClass IIb (EU MDR)
Ref 1007258Model Stapedioplasty prosthesisRef 1007254Ref 1007253Ref 1007209Ref 1007257Ref 1007255Ref 1007256
Identity
- Trade Name
- NiTiFLEX EUDAMED
- Device Name
- NiTiFLEX EUDAMED
- Model / Reference
- Stapedioplasty prosthesis EUDAMED1007258 EUDAMED1007254 EUDAMED1007253 EUDAMED1007209 EUDAMED1007257 EUDAMED1007255 EUDAMED1007256 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368832352 EUDAMED14250368832314 EUDAMED14250368832307 EUDAMED14250368832260 EUDAMED14250368832345 EUDAMED14250368832321 EUDAMED14250368832338 EUDAMED
- Basic UDI-DI
- B-14250368832352 EUDAMEDB-14250368832314 EUDAMEDB-14250368832307 EUDAMEDB-14250368832260 EUDAMEDB-14250368832345 EUDAMEDB-14250368832321 EUDAMEDB-14250368832338 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
NiTiFLEX 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-14250368832352 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (7)
- EUDAMED 55fc7417-fa3d-4708-8bac-e2cba34f5979 61 fields · synced Oct 6, 2026
- EUDAMED b5cce3ee-2cc5-4335-bf81-d0d990e7f543 61 fields · synced May 17, 2026
- EUDAMED ffbc0504-6013-4d30-b249-e65218ec2099 61 fields · synced May 17, 2026
- EUDAMED fad94920-ae64-4b8d-af35-d6a002dad697 61 fields · synced May 18, 2026
- EUDAMED 52830342-dd35-4a57-abd2-0f84243cdae2 61 fields · synced May 18, 2026
- EUDAMED 339a642e-4a84-4c59-a5b7-e2d3fc74935d 61 fields · synced May 18, 2026
- EUDAMED 4360b7e3-6ab5-4068-bcef-a498aff66878 61 fields · synced Jul 31, 2026