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Trachealspreizer, Modell: Laborde Dialator
EUDAMEDClass IIa (EU MDR)
Ref SIOK1450
Identity
- Trade Name
- Trachealspreizer, Modell: Laborde Dialator EUDAMED
- Device Name
- Trachealspreizer, Modell: Laborde Dialator EUDAMEDWundhaken | Retraktoren | Retractors EUDAMED
- Model / Reference
- SIOK1450 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14260526218263 EUDAMED
- Basic UDI-DI
- B-14260526218263 EUDAMED426052621SIBT0144 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 EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General internal orthopaedic fixation system implantation kit
Trachealspreizer, Modell: Laborde Dialator 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-14260526218263 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-14260526218263 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Scholz Medical GmbH
- EUDAMED SRN
- DE-MF-000008955
Sources (2)
- EUDAMED 0e22d873-da6f-43b6-a798-f08eee836d26 61 fields · synced Oct 6, 2026
- EUDAMED 4a139e5e-cf1a-4a8c-80d7-7b76bc466b29 61 fields · synced Jul 10, 2026