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MatriX Offset
EUDAMEDClass IIb (EU MDR)
Ref 1006036Model Stapedioplasty prosthesis
Identity
- Trade Name
- MatriX Offset EUDAMED
- Device Name
- MatriX Offset EUDAMED
- Model / Reference
- Stapedioplasty prosthesis EUDAMED1006036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368833342 EUDAMED
- Basic UDI-DI
- B-14250368833342 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-14250368833342 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (1)
- EUDAMED 644664a6-0800-4e59-be1b-46c0deef2d0d 61 fields · synced May 22, 2026