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Rol Pwdii50sf B Aim Cl K4
EUDAMEDFDA UDIClass I (EU MDR)
Ref ARDPWT309010AModel XL Series
by Maquet SAS
Identity
- Trade Name
- ROL PWDII50SF B AIM CL K4 EUDAMEDMaquet Rolite FDA UDI
- Generic Name
- Mobile examination/treatment room light FDA UDI
- Device Name
- Maquet Rolite EUDAMEDROL PWDII50SF B AIM CL K4 FDA UDI
- Model / Reference
- XL Series EUDAMEDARDPWT309010A EUDAMEDFDA UDI
- Description
- ROL PWDII50SF B AIM CL K4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712412067 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700712421281RA EUDAMED
- Direct Marketing DI
- 03700712412067 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
- Not 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
Rol Pwdii50sf B Aim Cl K4 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 | 3700712421281RA | 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 c6656f32-51d3-40fe-a77d-c6c7327fe3a5 61 fields · synced Jul 27, 2026
- FDA UDI d8c1242c-3565-4dbf-8747-7bb4022b0cc1 35 fields · synced May 30, 2026