Identity
- Trade Name
- Basis Set, fein EUDAMED
- Device Name
- Basis Set, fein EUDAMEDOperationssets EUDAMED
- Model / Reference
- S404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260526218877 EUDAMED14260526219741 EUDAMED
- Basic UDI-DI
- B-04260526218877 EUDAMED426052621SET17D EUDAMED
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
- Medical Purpose
- Die Operationssets bestehend aus verschiedenen Einmalinstrumenten und Ergänzungsmaterialien zur Durchführung der im Produktnamen benannten Behandlung. Der Verwendungszweck der Behandlungseinheit ergibt sich aus der Zweckbestimmung der enthaltenen Einmalinstrumente und des Zubehörs. Die OP-Sets sind für den einmaligen Gebrauch ausgelegt. Die OP-Sets stellen dem Anwender in einer gebrauchsfertigen Kombination verschiedene Komponenten (Einmalinstrumente und Zubehör) zur Verfügung. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Category: General internal orthopaedic fixation system implantation kit
Basis Set, fein by Scholz Medical GmbH — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04260526218877 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04260526218877 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Scholz Medical GmbH
- EUDAMED SRN
- DE-MF-000008955
Sources (2)
- EUDAMED 1a44e83c-5fe4-4b51-a2ff-c80c64e63c07 61 fields · synced Oct 6, 2026
- EUDAMED 4b7601a5-0fcd-4107-89ca-7845e9698213 61 fields · synced Jul 21, 2026