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 HAND 2.0-2.5 FDA UDI
- Model / Reference
- G02 10031 EUDAMEDFDA UDI
- Description
- NEOSYS SINGLE USE SET HAND 2.0-2.5 FDA UDI
Identifiers
- Catalog Number
- G02 10031 FDA UDI
- Primary DI / UDI-DI
- 03701337606107 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701337606107 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Neosys by In2Bones SAS — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03701337606107 | 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 (3)
- EUDAMED 67f53638-0056-4c97-83c9-54556f6067bc 61 fields · synced Jun 18, 2026
- FDA UDI 2d7cf353-019b-4380-9109-7da3ea5bc63c 35 fields · synced May 29, 2026
- EUDAMED cf73a9ef-7351-4d9d-8809-a7e5934b95ed 61 fields · synced Jun 18, 2026