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Quantum
EUDAMEDFDA UDIClass I (EU MDR)
Ref M05 10014Model A06 10011
by In2Bones SAS
Identity
- Trade Name
- QUANTUM EUDAMEDFDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- QUANTUM Rack Revision FDA UDI
- Model / Reference
- A06 10011 EUDAMEDM05 10014 EUDAMEDFDA UDI
- Description
- QUANTUM Rack Revision FDA UDI
Identifiers
- Catalog Number
- M05 10014 FDA UDI
- Primary DI / UDI-DI
- 03701337606541 EUDAMEDFDA UDI
- Basic UDI-DI
- 3701337640927F EUDAMED
- Direct Marketing DI
- 03701337606541 EUDAMED
- 510(k) Number
- K191380 FDA UDI
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
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
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 I — 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 | 3701337640927F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (2)
- EUDAMED 10d538e6-9316-4bf8-9a9b-e95802b885c1 61 fields · synced May 30, 2026
- FDA UDI fb6c8abe-d12e-4f6d-9f92-1b6f58a386b3 36 fields · synced May 30, 2026