Identity
- Trade Name
- EQTXHS016 SAX16 EUDAMEDMaquet Equipment FDA UDI
- Generic Name
- Medical monitor/light mount FDA UDI
- Device Name
- Maquet Equipment EUDAMEDEQTXHS016 SAX16 FDA UDI
- Model / Reference
- ARDEQT639020A EUDAMEDFDA UDI
- Description
- EQTXHS016 SAX16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712422332 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700712421267RG EUDAMED
- Direct Marketing DI
- 03700712422332 EUDAMED
- FDA Product Code
- FXR FDA UDI
- EMDN Code
- Z12010799 SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER EUDAMED
- GMDN Term
- Medical monitor/light mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- France 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Eqtxhs016 Sax16 by Maquet 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 | 3700712421267RG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maquet SAS
- EUDAMED SRN
- FR-MF-000002926
Sources (2)
- EUDAMED 5a7bfa72-00e5-4ccf-8336-32676e0491db 61 fields · synced Jul 18, 2026
- FDA UDI af435004-0b19-4fe7-8f4d-a8aea663ec2c 34 fields · synced May 30, 2026