← Back to catalogue
Ezea33df Tk Sb0810
EUDAMEDFDA UDIClass I (EU MDR)
Ref ARDEZA209007A
by Maquet SAS
Identity
- Trade Name
- EZEA33DF TK SB0810 EUDAMEDMaquet Ezea FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- Maquet Ezea EUDAMEDEZEA33DF TK SB0810 FDA UDI
- Model / Reference
- ARDEZA209007A EUDAMEDFDA UDI
- Description
- EZEA33DF TK SB0810 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712432492 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700712432942SM EUDAMED
- Direct Marketing DI
- 03700712432492 EUDAMED
- FDA Product Code
- FTD 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
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
Category: Operating room light system
Ezea33df Tk Sb0810 by Maquet Sas — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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 (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 | 3700712432942SM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maquet SAS
- EUDAMED SRN
- FR-MF-000002926
Sources (2)
- EUDAMED 4d5b59a6-daa8-40d9-b157-1c44bb391885 61 fields · synced Jun 19, 2026
- FDA UDI d978e35e-f5d3-4c3c-83a4-aeeaef8cc0c5 34 fields · synced May 30, 2026