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Rol Pwdii70sf K3 B
EUDAMEDFDA UDIClass I (EU MDR)
Ref ARDROL309045AModel XL Series
by Maquet SAS
Identity
- Trade Name
- ROL PWDII70SF K3 B EUDAMEDMaquet Rolite FDA UDI
- Generic Name
- Mobile examination/treatment room light FDA UDI
- Device Name
- Maquet Rolite EUDAMEDROL PWDII70SF K3 B FDA UDI
- Model / Reference
- XL Series EUDAMEDARDROL309045A EUDAMEDFDA UDI
- Description
- ROL PWDII70SF K3 B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712422769 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700712421281RA EUDAMED
- Direct Marketing DI
- 03700712422769 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
Rol Pwdii70sf K3 B 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 4b0a54e7-0b58-4d36-b1b6-6deed961b3cd 61 fields · synced Jul 19, 2026
- FDA UDI ecffdac4-d483-4e3d-8018-59ebc9d7ced8 34 fields · synced May 30, 2026