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K-Piston
EUDAMEDClass IIb (EU MDR)
Ref 1006166Model Stapedioplasty prosthesisRef 1006116Ref 1006157Ref 1006105Ref 1006103Ref 1006159Ref 1006161Ref 1006109Ref 1006104Ref 1006107Ref 1006156Ref 1006162Ref 1006155Ref 1006170Ref 1006112Ref 1006153Ref 1006114Ref 1006108
Identity
- Trade Name
- K-Piston EUDAMED
- Device Name
- K-Piston EUDAMED
- Model / Reference
- Stapedioplasty prosthesis EUDAMED1006166 EUDAMED1006116 EUDAMED1006157 EUDAMED1006105 EUDAMED1006103 EUDAMED1006159 EUDAMED1006161 EUDAMED1006109 EUDAMED1006104 EUDAMED1006107 EUDAMED1006156 EUDAMED1006162 EUDAMED1006155 EUDAMED1006170 EUDAMED1006112 EUDAMED1006153 EUDAMED1006114 EUDAMED1006108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368830266 EUDAMED14250368830129 EUDAMED14250368830198 EUDAMED14250368830037 EUDAMED14250368830013 EUDAMED14250368830211 EUDAMED14250368830235 EUDAMED14250368830075 EUDAMED14250368830020 EUDAMED14250368830051 EUDAMED14250368830181 EUDAMED14250368830242 EUDAMED14250368830174 EUDAMED14250368830280 EUDAMED14250368830105 EUDAMED14250368830150 EUDAMED14250368830112 EUDAMED14250368830068 EUDAMED
- Basic UDI-DI
- B-14250368830266 EUDAMEDB-14250368830129 EUDAMEDB-14250368830198 EUDAMEDB-14250368830037 EUDAMEDB-14250368830013 EUDAMEDB-14250368830211 EUDAMEDB-14250368830235 EUDAMEDB-14250368830075 EUDAMEDB-14250368830020 EUDAMEDB-14250368830051 EUDAMEDB-14250368830181 EUDAMEDB-14250368830242 EUDAMEDB-14250368830174 EUDAMEDB-14250368830280 EUDAMEDB-14250368830105 EUDAMEDB-14250368830150 EUDAMEDB-14250368830112 EUDAMEDB-14250368830068 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
K-Piston 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-14250368830266 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (18)
- EUDAMED d3ce5fcb-9bb4-4668-9122-08ef542ca939 61 fields · synced Oct 6, 2026
- EUDAMED 70426567-5805-4e4d-af99-5d240b6f28f2 61 fields · synced May 16, 2026
- EUDAMED a6dc140a-affd-451d-a849-8c81a4a95491 61 fields · synced May 16, 2026
- EUDAMED d9f3c5a1-7e37-4fb2-b4cb-01452d032058 61 fields · synced May 16, 2026
- EUDAMED 72245730-d888-461c-9535-704fc0afebfa 61 fields · synced May 16, 2026
- EUDAMED c24a34b3-b2cc-4411-ad8e-1377ff9d197c 61 fields · synced May 16, 2026
- EUDAMED aec9e5db-4163-4ff4-bc74-47e8a04adccd 61 fields · synced May 17, 2026
- EUDAMED fc8f1fde-71d6-4498-b87a-64ba043e2a5f 61 fields · synced May 17, 2026
- EUDAMED a38bdd1b-f5d4-4129-a852-991a83fb8f39 61 fields · synced May 17, 2026
- EUDAMED 7ba9f2be-dcc1-4a57-9e73-6243e043c6aa 61 fields · synced May 17, 2026
- EUDAMED d2c7e484-664a-4621-8873-28ec2d63deea 61 fields · synced May 17, 2026
- EUDAMED 5adbc33a-753c-4e91-97f1-e2196c239a92 61 fields · synced May 18, 2026
- EUDAMED 2a35e649-0989-42b4-b487-3d0e12201735 61 fields · synced May 18, 2026
- EUDAMED 7cfd4e41-16cf-4d48-8ca3-612e29c53771 61 fields · synced May 18, 2026
- EUDAMED 2ee9a62e-0a82-49f0-97c6-bb4095d125b2 61 fields · synced May 18, 2026
- EUDAMED 431f0597-2019-451c-8dc0-50011ca74acb 61 fields · synced Jun 20, 2026
- EUDAMED 4e1a6895-7d11-4817-a91b-eab368b939c4 61 fields · synced Jul 12, 2026
- EUDAMED efe8732e-3f5b-4a57-879a-5c70b7f20d26 61 fields · synced Aug 3, 2026