Identity
- Trade Name
- Shark Screw® driver ht EUDAMED
- Device Name
- Eindrehinstrumente (Insertion Instruments) EUDAMED
- Model / Reference
- SCDRVh EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120125220266 EUDAMED
- Basic UDI-DI
- 9120125220014E EUDAMED
- Direct Marketing DI
- 09120125220266 EUDAMED
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Shark Screw® driver ht by surgebright GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 9120125220014E | Class I | Active |
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Manufacturer
- Manufacturer
- surgebright GmbH
- EUDAMED SRN
- AT-MF-000002664
Sources (1)
- EUDAMED b458e634-5f4a-4856-9ae6-2d4faf4563d4 61 fields · synced Jun 17, 2026