Identity
- Trade Name
- AMX Navigate UPGRADE EUDAMEDAMX FDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, digital FDA UDI
- Device Name
- AMX Navigate EUDAMEDAMX Navigate Upgrade Designated Medical Device Assembly FDA UDI
- Model / Reference
- 5844925-1 EUDAMEDNAVIGATE UPGRADE FDA UDI
- Description
- AMX Navigate Upgrade Designated Medical Device Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278798374 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00267HN EUDAMED
- 510(k) Number
- K210982 FDA UDI
- FDA Product Code
- IZL FDA UDIMQB FDA UDI
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
- GMDN Term
- Mobile basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1720 FDA UDI892.1680 FDA UDI
- Market of Registration
- Finland 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
AMX Navigate UPGRADE by Ge Medical Systems, Inc. — Class IIb — 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 | 8406821BUG00267HN | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
- EUDAMED SRN
- US-MF-000018315
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED e62d4748-ca47-448c-bd06-2880932e992a 61 fields · synced Jun 18, 2026
- FDA UDI afb25c68-a4ae-4107-b56d-60f4fda85f23 35 fields · synced May 30, 2026