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Bone Surgical Engine set
EUDAMEDClass IIa (EU MDR)
Ref TRT12NSHRef TRT12NOSRef TRT12NSGRef CST10XXRef TST10XXRef TRT12NRC
Identity
- Trade Name
- Bone Surgical Engine set EUDAMED
- Device Name
- Bone Surgical Engine set EUDAMED
- Model / Reference
- TRT12NSH EUDAMEDTRT12NOS EUDAMEDTRT12NSG EUDAMEDCST10XX EUDAMEDTST10XX EUDAMEDTRT12NRC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260473959 EUDAMED08809260475427 EUDAMED08809260475441 EUDAMED08809260475472 EUDAMED08809260475502 EUDAMED08809260475434 EUDAMED
- Basic UDI-DI
- B-08809260473959 EUDAMEDB-08809260475427 EUDAMEDB-08809260475441 EUDAMEDB-08809260475472 EUDAMEDB-08809260475502 EUDAMEDB-08809260475434 EUDAMED
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Category: Electrical-only medical device connection cable, reusable
Bone Surgical Engine set by Saeshin Precision Co., Ltd. — Class IIa — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809260473959 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Saeshin Precision Co., Ltd.
- EUDAMED SRN
- KR-MF-000016345
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (6)
- EUDAMED a17d72bf-c4c4-46d6-a568-d50b85ad7e7e 61 fields · synced Jul 28, 2026
- EUDAMED 534abd7b-07e0-42c3-93b3-fc02209870e0 61 fields · synced May 18, 2026
- EUDAMED 8057c0b4-ce28-43da-9b15-b3bf94784768 61 fields · synced May 18, 2026
- EUDAMED 0acb6b4e-1f7f-406b-aecc-ffbea37879c9 61 fields · synced May 19, 2026
- EUDAMED c19bcfbf-2cb2-4ba5-811b-f7c99b27fac4 61 fields · synced May 19, 2026
- EUDAMED 6b3db088-2d12-448b-9f08-0740cbcd491b 61 fields · synced May 19, 2026