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Duesseldorf Bell Partial
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 1002034Model Tympanoplasty prosthesis
Identity
- Trade Name
- Duesseldorf Bell Partial EUDAMED
- Device Name
- Duesseldorf Bell Partial EUDAMED
- Model / Reference
- Tympanoplasty prosthesis EUDAMED1002034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368810206 EUDAMED
- Basic UDI-DI
- B-14250368810206 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
Duesseldorf Bell Partial by Heinz Kurz GmbH — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972492 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-14250368810206 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (2)
- EUDAMED 98216dac-ea78-4021-ad89-4dc859d21144 61 fields · synced Oct 7, 2026
- FDA 510(k) K972492 1 fields · synced May 18, 2026