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Skarzynski Piston
EUDAMEDClass IIb (EU MDR)
Ref 1006069Model Stapedioplasty prosthesisRef 1006065Ref 1006081Ref 1006054Ref 1006067Ref 1006068Ref 1006079Ref 1006078Ref 1006053Ref 1006064Ref 1006073Ref 1006059Ref 1006056Ref 1006066Ref 1006074
Identity
- Trade Name
- Skarzynski Piston EUDAMED
- Device Name
- Skarzynski Piston EUDAMED
- Model / Reference
- Stapedioplasty prosthesis EUDAMED1006069 EUDAMED1006065 EUDAMED1006081 EUDAMED1006054 EUDAMED1006067 EUDAMED1006068 EUDAMED1006079 EUDAMED1006078 EUDAMED1006053 EUDAMED1006064 EUDAMED1006073 EUDAMED1006059 EUDAMED1006056 EUDAMED1006066 EUDAMED1006074 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368830365 EUDAMED14250368830327 EUDAMED14250368832888 EUDAMED14250368832710 EUDAMED14250368830341 EUDAMED14250368830358 EUDAMED14250368832864 EUDAMED14250368832857 EUDAMED14250368832703 EUDAMED14250368830310 EUDAMED14250368832802 EUDAMED14250368832772 EUDAMED14250368832741 EUDAMED14250368830334 EUDAMED14250368832819 EUDAMED
- Basic UDI-DI
- B-14250368830365 EUDAMEDB-14250368830327 EUDAMEDB-14250368832888 EUDAMEDB-14250368832710 EUDAMEDB-14250368830341 EUDAMEDB-14250368830358 EUDAMEDB-14250368832864 EUDAMEDB-14250368832857 EUDAMEDB-14250368832703 EUDAMEDB-14250368830310 EUDAMEDB-14250368832802 EUDAMEDB-14250368832772 EUDAMEDB-14250368832741 EUDAMEDB-14250368830334 EUDAMEDB-14250368832819 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
Skarzynski 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-14250368830365 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (15)
- EUDAMED 6b72722f-b018-43c9-9d07-614fe96900cc 61 fields · synced Oct 6, 2026
- EUDAMED 5e0d3951-68ab-419c-885b-5f5e0f45becd 61 fields · synced May 16, 2026
- EUDAMED 38514ae2-46c9-46ab-81e7-7115308fbc3e 61 fields · synced May 16, 2026
- EUDAMED b5c75b68-eed8-4ebb-807c-b752ec33fc87 61 fields · synced May 16, 2026
- EUDAMED 4b39f224-94b9-44fa-b37f-7c81b269a216 61 fields · synced May 17, 2026
- EUDAMED 0668aaf2-f3cb-4f15-8f50-c012907c667c 61 fields · synced May 17, 2026
- EUDAMED c0ae674a-8b7f-4e8c-93dd-8b5c1f7870ff 61 fields · synced May 17, 2026
- EUDAMED 900fa999-dbf8-4499-ab5b-259cabd3c5df 61 fields · synced May 17, 2026
- EUDAMED 89915c63-9700-47d3-9d3d-915e2311c554 61 fields · synced May 17, 2026
- EUDAMED bfe626d1-2c55-45c6-b090-77f87f423e94 61 fields · synced May 18, 2026
- EUDAMED 07a58a2e-7d9d-4e90-be32-e80e04d3e452 61 fields · synced May 18, 2026
- EUDAMED deb7fb1f-b1f0-4470-9d56-c4ddab5691b8 61 fields · synced May 18, 2026
- EUDAMED c89cab70-0180-4be2-84bb-9d42661ba331 61 fields · synced May 18, 2026
- EUDAMED 1a9a5c9e-7cc6-42f4-96ee-6b6e370a792d 61 fields · synced Jul 10, 2026
- EUDAMED 9fcd024c-f00b-40bf-84b8-4216d8670d7f 61 fields · synced Aug 2, 2026