Neosys
EUDAMEDFDA UDIClass IIa (EU MDR)
by In2Bones SAS
Identity
- Trade Name
- NEOSYS EUDAMEDFDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- NEOSYS SINGLE USE INTRUMENTS SET EUDAMEDNEOSYS SINGLE USE SET FOOT 2.0-2.5 FDA UDINEOSYS SINGLE USE SET FOOT DMMO FDA UDINEOSYS SINGLE USE SET FOOT 2.0-2.5 DRILL "M" FDA UDINEOSYS SINGLE USE SET COMPLETE FDA UDINEOSYS SET SINGLE USE INSTRUMENTS FDA UDINEOSYS SINGLE USE SET FOOT 3.0-3.5 CANN DRILL "S" FDA UDINEOSYS SINGLE USE SET FOOT 2.0-2.5 CANN DRILL "S" FDA UDINEOSYS SINGLE USE SET FOOT 3.0-3.5 FDA UDINEOSYS SINGLE USE SET FOOT 2.0-2.5 DMMO FDA UDI
- Model / Reference
- G02 10001 EUDAMEDFDA UDIG02 10041 EUDAMEDFDA UDIG02 10191 EUDAMEDFDA UDIG02 10131 EUDAMEDFDA UDIG02 10051 EUDAMEDFDA UDIG02 10021 EUDAMEDFDA UDIG02 10101 EUDAMEDFDA UDIG02 10121 EUDAMEDFDA UDIG02 10071 EUDAMEDFDA UDI
- Description
- NEOSYS SINGLE USE SET FOOT 2.0-2.5 FDA UDINEOSYS SINGLE USE SET FOOT DMMO FDA UDINEOSYS SINGLE USE SET FOOT 2.0-2.5 DRILL "M" FDA UDINEOSYS SINGLE USE SET COMPLETE FDA UDINEOSYS SET SINGLE USE INSTRUMENTS FDA UDINEOSYS SINGLE USE SET FOOT 3.0-3.5 CANN DRILL "S" FDA UDINEOSYS SINGLE USE SET FOOT 2.0-2.5 CANN DRILL "S" FDA UDINEOSYS SINGLE USE SET FOOT 3.0-3.5 FDA UDINEOSYS SINGLE USE SET FOOT 2.0-2.5 DMMO FDA UDI
Identifiers
- Catalog Number
- G02 10021 FDA UDIG02 10121 FDA UDIG02 10101 FDA UDIG02 10191 FDA UDIG02 10001 FDA UDIG02 10071 FDA UDIG02 10051 FDA UDIG02 10041 FDA UDIG02 10131 FDA UDI
- Primary DI / UDI-DI
- 03760225712191 EUDAMEDFDA UDI03701337606114 EUDAMEDFDA UDI03701337606275 EUDAMEDFDA UDI03701337606206 EUDAMEDFDA UDI03701337606121 EUDAMEDFDA UDI03701337606091 EUDAMEDFDA UDI03701337606176 EUDAMEDFDA UDI03701337606190 EUDAMEDFDA UDI03701337606145 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225712191 EUDAMEDB-03701337606114 EUDAMEDB-03701337606275 EUDAMEDB-03701337606206 EUDAMEDB-03701337606121 EUDAMEDB-03701337606091 EUDAMEDB-03701337606176 EUDAMEDB-03701337606190 EUDAMEDB-03701337606145 EUDAMED
- FDA Product Code
- KDD FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Joint prosthesis implantation kit, single-use
Neosys by In2Bones SAS — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760225712191 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (27)
- EUDAMED e41f713d-c722-40cf-9f47-34337eae43a7 61 fields · synced Aug 3, 2026
- EUDAMED c25e103c-3b10-4cce-bb14-62e5a8a45d14 61 fields · synced May 16, 2026
- EUDAMED 31d52a3b-77ea-4879-9825-209216d492b6 61 fields · synced May 17, 2026
- EUDAMED e2214eed-c77b-4021-adf0-8a5e5d982745 61 fields · synced May 17, 2026
- EUDAMED bd31c35f-4dfa-4272-b4f6-3fc20362a6b6 61 fields · synced May 18, 2026
- EUDAMED 83ee3317-ea4d-467b-8b69-cf5c841a5446 61 fields · synced May 18, 2026
- EUDAMED 43ca5065-0e45-43f1-b805-6714608d8b39 61 fields · synced May 18, 2026
- EUDAMED deef86e9-8a9c-4557-88e3-80ba455de6eb 61 fields · synced May 18, 2026
- EUDAMED 81e3b20f-3499-4c8c-b044-74201bd67ae1 61 fields · synced May 19, 2026
- FDA UDI 5cbc13db-076a-4a14-b639-571a6f81e0f2 35 fields · synced May 26, 2026
- FDA UDI dedc849b-8205-4bc9-b607-76001510629f 35 fields · synced May 29, 2026
- FDA UDI 27b12135-5498-4e95-a6dd-c43342454f26 35 fields · synced May 30, 2026
- FDA UDI 0022b491-7cfe-4939-86df-cd905d17a50b 35 fields · synced May 30, 2026
- FDA UDI 7240149d-87f3-45e7-9d87-16ac776d695e 35 fields · synced May 30, 2026
- FDA UDI 629bd2bd-70c9-4b4a-a828-7508b3c1d7cb 35 fields · synced May 30, 2026
- FDA UDI d21296d8-30a7-4287-96e5-9f1b0c33887c 35 fields · synced May 30, 2026
- FDA UDI 6560dec8-0b05-4c76-9683-02b6652a3752 35 fields · synced May 30, 2026
- FDA UDI dc7aea0e-5567-43ba-97b3-e625d01dc13b 35 fields · synced May 30, 2026
- EUDAMED c3156d0c-5a7a-473c-b8ba-63f77736791d 61 fields · synced Jul 9, 2026
- EUDAMED ed7b40e0-436f-41ee-be33-e2bce53a354b 61 fields · synced Jul 11, 2026
- EUDAMED 11ee2061-1b23-427b-91f2-1e7ae1cb75c5 61 fields · synced Jul 15, 2026
- EUDAMED eaa87d34-aa4c-4585-aad1-2f62f98e5cb5 61 fields · synced Jul 17, 2026
- EUDAMED 97592365-689b-4433-9025-7d73bf5ffb91 61 fields · synced Jul 26, 2026
- EUDAMED 2c8ee820-123d-4640-b9ae-2265888dec94 61 fields · synced Jul 27, 2026
- EUDAMED 9e6ec2a5-d6ce-430a-ad5e-fd5f3f4f3fb0 61 fields · synced Jul 30, 2026
- EUDAMED 37a8050d-94b6-4a06-b0bc-e6fb23ee3aaf 61 fields · synced Aug 2, 2026
- EUDAMED 47a2bc7a-3e63-44be-9521-3ab09faaa2d4 61 fields · synced Aug 3, 2026