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Vstii40sf Tk Satx13
EUDAMEDFDA UDIClass I (EU MDR)
Ref ARDSAT609075AModel Volista Standop II
by Maquet SAS
Identity
- Trade Name
- VSTII40SF TK SATX13 EUDAMEDVolista FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- Volista EUDAMEDVSTII40SF TK SATX13 FDA UDI
- Model / Reference
- Volista Standop II EUDAMEDARDSAT609075A EUDAMEDFDA UDI
- Description
- VSTII40SF TK SATX13 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712422189 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700712432614RZ EUDAMED
- Direct Marketing DI
- 03700712422189 EUDAMED
- 510(k) Number
- K130513 FDA UDI
- FDA Product Code
- FSY FDA UDI
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 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
No
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
Vstii40sf Tk Satx13 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 | 3700712432614RZ | 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 4449a93a-ffbd-4b42-b3be-4208be1760c9 61 fields · synced Jun 19, 2026
- FDA UDI 52e89f8c-2b22-4e9d-a303-c30fa60cf358 35 fields · synced May 30, 2026