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MatriX Offset
EUDAMEDClass IIb (EU MDR)
Ref 1006034Model Stapedioplasty prosthesisRef 1006035Ref 1006033Ref 1006037
Identity
- Trade Name
- MatriX Offset EUDAMED
- Device Name
- MatriX Offset EUDAMED
- Model / Reference
- Stapedioplasty prosthesis EUDAMED1006034 EUDAMED1006035 EUDAMED1006033 EUDAMED1006037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368833328 EUDAMED14250368833335 EUDAMED14250368833311 EUDAMED14250368833359 EUDAMED
- Basic UDI-DI
- B-14250368833328 EUDAMEDB-14250368833335 EUDAMEDB-14250368833311 EUDAMEDB-14250368833359 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
MatriX Offset 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-14250368833328 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (4)
- EUDAMED a20ff269-05d7-49b8-8fca-1b184907d38b 61 fields · synced Jul 25, 2026
- EUDAMED a21a8594-a31b-479b-8925-905721971568 61 fields · synced May 17, 2026
- EUDAMED 7184eafe-f75d-49cb-a78f-36dd4d09d13a 61 fields · synced May 18, 2026
- EUDAMED 45ab553d-d17e-47c2-aad0-2a83b1a02715 61 fields · synced May 19, 2026