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Vcsii64sfdf Tk Sb1011
EUDAMEDFDA UDIClass I (EU MDR)
Ref ARDVCS209057AModel Volista Access II
by Maquet SAS
Identity
- Trade Name
- VCSII64SFDF TK SB1011 EUDAMEDVolista FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- Volista EUDAMEDVCSII64SFDF TK SB1011 FDA UDI
- Model / Reference
- Volista Access II EUDAMEDARDVCS209057A EUDAMEDFDA UDI
- Description
- VCSII64SFDF TK SB1011 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712435882 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700712432607S4 EUDAMED
- Direct Marketing DI
- 03700712435882 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
Category: Operating room light system
Vcsii64sfdf Tk Sb1011 by Maquet Sas — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 3700712432607S4 | 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 4ad1a552-3f42-4c3d-b4c1-159b0a7e6377 61 fields · synced Jul 14, 2026
- FDA UDI e87ee7a0-4ae3-483a-8101-880b7367e889 35 fields · synced May 30, 2026