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Rolm Ezea30sf
EUDAMEDFDA UDIClass I (EU MDR)
Ref ARDROL309058AModel M Series
by Maquet SAS
Identity
- Trade Name
- ROLM EZEA30SF EUDAMEDMaquet Rolite FDA UDI
- Generic Name
- Mobile examination/treatment room light FDA UDI
- Device Name
- Maquet Rolite EUDAMEDROLM EZEA30SF FDA UDI
- Model / Reference
- M Series EUDAMEDARDROL309058A EUDAMEDFDA UDI
- Description
- ROLM EZEA30SF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712432539 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700712432959T6 EUDAMED
- Direct Marketing DI
- 03700712432539 EUDAMED
- FDA Product Code
- FSS FDA UDI
- EMDN Code
- Z12010702 MOBILE SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Mobile examination/treatment 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
Rolm Ezea30sf 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 | 3700712432959T6 | 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 1b4b2d88-c99f-4cc1-8acb-6068b481aa27 61 fields · synced Jul 19, 2026
- FDA UDI 662648b3-6c2f-4408-80ca-856b1389ddd4 34 fields · synced May 30, 2026