Identity
- Trade Name
- Key Stainless Steel EUDAMED
- Device Name
- Cutting Instruments EUDAMED
- Model / Reference
- OR-036-90 EUDAMEDOR-098-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055445936396 EUDAMED05055445937423 EUDAMED
- Basic UDI-DI
- 50554459CUTTINGINSTRL2 EUDAMED
- EMDN Code
- L090902 ORTHOPAEDIC SURGERY TREPHINES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Category: Bone trephine, reusable
Key Stainless Steel by Surtex Instruments Ltd — Class I — MDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50554459CUTTINGINSTRL2 | Class I | Active |
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Manufacturer
- Manufacturer
- Surtex Instruments Ltd
- EUDAMED SRN
- GB-MF-000023183
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 9f330f0c-df27-4fda-b761-46382b47ad4e 61 fields · synced Jul 13, 2026
- EUDAMED 1f7d7926-bfe3-406b-89e7-d374cd7fe8b6 61 fields · synced May 19, 2026