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Quantum
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M05 00155Model M05 00143
by In2Bones SAS
Identity
- Trade Name
- QUANTUM EUDAMEDFDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- QUANTUM Insert Trial Right Size 3, Thickness 7 FDA UDI
- Model / Reference
- M05 00143 EUDAMEDM05 00155 EUDAMEDFDA UDI
- Description
- QUANTUM Insert Trial Right Size 3, Thickness 7 FDA UDI
Identifiers
- Catalog Number
- M05 00155 FDA UDI
- Primary DI / UDI-DI
- 03701337613617 EUDAMEDFDA UDI
- Basic UDI-DI
- 3701337619197V EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Quantum by In2Bones SAS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3701337619197V | 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 (2)
- EUDAMED 7146afb2-827f-42aa-8bbe-21c13c5bb186 61 fields · synced May 30, 2026
- FDA UDI f229ed4a-deef-4bfe-a8e2-39c0003b7803 35 fields · synced May 30, 2026