Identity
- Trade Name
- Reusable Surgical Instrument EUDAMED
- Device Name
- Surgical Instrument EUDAMED
- Model / Reference
- 110045295 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800071019749 EUDAMED
- Basic UDI-DI
- B-08800071019749 EUDAMED
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Reusable Surgical Instrument by OSTEONIC CO., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800071019749 | Class I | Active |
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Manufacturer
- Manufacturer
- OSTEONIC Co., Ltd.
- EUDAMED SRN
- KR-MF-000008969
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED bb3256cb-2c55-43fd-bb60-0462e9fe0e66 61 fields · synced Jun 19, 2026