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Regensburg Total
EUDAMEDClass IIb (EU MDR)
Ref 1004462Model Tympanoplasty prosthesis
Identity
- Trade Name
- Regensburg Total EUDAMED
- Device Name
- Regensburg Total EUDAMED
- Model / Reference
- Tympanoplasty prosthesis EUDAMED1004462 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368820847 EUDAMED
- Basic UDI-DI
- B-14250368820847 EUDAMED
- EMDN Code
- P02010101 OSSICULAR PROSTHESES (PORP AND TORP) 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
Regensburg Total 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-14250368820847 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (1)
- EUDAMED 1bdaa5dd-1d41-473c-beab-cd4e99545551 61 fields · synced May 22, 2026