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Bone Awl With Eye 16 cm - 6 1/4" 3.2 mm Stainless Steel
EUDAMEDClass I (EU MDR)
Ref OR-025-32Model 50554459CHLGOUGIRL090993N
Identity
- Trade Name
- Bone Awl With Eye 16 cm - 6 1/4" 3.2 mm Stainless Steel EUDAMED
- Device Name
- Cutting Instruments EUDAMEDReusable surgical instruments EUDAMED
- Model / Reference
- OR-025-32 EUDAMED50554459CHLGOUGIRL090993N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056111358764 EUDAMED
- Basic UDI-DI
- 50554459CUTTINGINSTRL2 EUDAMEDB-05056111358764 EUDAMED
- EMDN Code
- L090902 ORTHOPAEDIC SURGERY TREPHINES, REUSABLE EUDAMEDL090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER 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
Bone Awl With Eye 16 cm - 6 1/4" 3.2 mm Stainless Steel by Surtex Instruments Ltd — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Bone trephine, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 50554459CUTTINGINSTRL2 | Class I | Active |
| 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 7edc6ada-c22d-4ecb-b743-595a9934b963 61 fields · synced Oct 7, 2026
- EUDAMED f6f9e793-a448-4ca5-8aa2-cf842c9d0354 61 fields · synced Sep 30, 2026