Neosys, Ibs
EUDAMEDFDA UDIClass IIa (EU MDR)
by In2Bones SAS
Identity
- Trade Name
- NEOSYS, IBS EUDAMEDFDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- NEOSYS SINGLE USE SET FOOT EUDAMEDNEOSYS SINGLE USE SET FOOT IBS 2.5C 16-18 FDA UDINEOSYS SINGLE USE SET FOOT IBS 3.0C 16-18 FDA UDI
- Model / Reference
- G02 10171 EUDAMEDFDA UDIG02 10181 EUDAMEDFDA UDI
- Description
- NEOSYS SINGLE USE SET FOOT IBS 2.5C 16-18 FDA UDINEOSYS SINGLE USE SET FOOT IBS 3.0C 16-18 FDA UDI
Identifiers
- Catalog Number
- G02 10171 FDA UDIG02 10181 FDA UDI
- Primary DI / UDI-DI
- 03701337606244 EUDAMEDFDA UDI03701337606268 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701337606244 EUDAMEDB-03701337606268 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, Ibs 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-03701337606244 | 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 (6)
- EUDAMED 39094a4a-b51e-4695-a033-77a38a64f5df 61 fields · synced Aug 1, 2026
- EUDAMED 1c369465-bf81-46b0-bdf8-aa59de609b88 61 fields · synced May 17, 2026
- FDA UDI 67707934-c2d1-4c55-be85-f3991049dce6 35 fields · synced May 29, 2026
- FDA UDI 6bd20e17-8f50-4a91-9542-6384d3b467f2 35 fields · synced May 30, 2026
- EUDAMED a0c8855b-9107-43c9-a2b5-b44bb9516703 61 fields · synced Jul 28, 2026
- EUDAMED 13e10eea-db25-499c-8fd9-563e672c51d8 61 fields · synced Aug 1, 2026