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Pwdii70df K4 Xhs021 Sax1012
EUDAMEDFDA UDIClass I (EU MDR)
Ref ARDPWT639311A
by Maquet SAS
Identity
- Trade Name
- PWDII70DF K4 XHS021 SAX1012 EUDAMEDMaquet PowerLED II FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- Maquet PowerLED II EUDAMEDPWDII70DF K4 XHS021 SAX1012 FDA UDI
- Model / Reference
- ARDPWT639311A EUDAMEDFDA UDI
- Description
- PWDII70DF K4 XHS021 SAX1012 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712428037 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700712421298RT EUDAMED
- Direct Marketing DI
- 03700712428037 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
Pwdii70df K4 Xhs021 Sax1012 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 | 3700712421298RT | 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 4deced47-2b9e-4f68-9afd-19dac1c13ae5 61 fields · synced Jun 19, 2026
- FDA UDI 67c16df2-36dd-4574-8e46-7a3df1304d5a 34 fields · synced May 30, 2026