← Back to catalogue
Vcsii64df Tk Sax1416
EUDAMEDClass I (EU MDR)
Ref ARDVCS629116AModel Volista Access II
by Maquet SAS
Identity
- Trade Name
- VCSII64DF TK SAX1416 EUDAMED
- Device Name
- Volista EUDAMED
- Model / Reference
- Volista Access II EUDAMEDARDVCS629116A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700712438463 EUDAMED
- Basic UDI-DI
- 3700712432607S4 EUDAMED
- Direct Marketing DI
- 03700712438463 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Operating room light system
Vcsii64df Tk Sax1416 by Maquet Sas — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Operating room light system.
- SLS 9000 — Avante · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
- 150/430/3130 Mach LED 150F Ceiling System — KENEX (ELECTRO-MEDICAL) LIMITED · Class I
- SYSTEM TWO LED — Medical Illumination International, Inc · Class II
- Operating Light — Weihai Wego Qiquan Medical Equipment Co., Ltd. · Class I
- HarmonyAIR — STERIS CORPORATION · Class II
- S300 Series — DENTIS CO. , LTD · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3700712432607S4 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maquet SAS
- EUDAMED SRN
- FR-MF-000002926
Sources (1)
- EUDAMED c3c12187-b83a-4a0b-b21b-baae24e4fab7 61 fields · synced Aug 3, 2026