Pwdii70sf Aim Mhs021 K3 1116
EUDAMEDFDA UDIClass I (EU MDR)
by Maquet SAS
Identity
- Trade Name
- PWDII70SF AIM MHS021 K3 1116 EUDAMEDMaquet PowerLED II FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- Maquet PowerLED II EUDAMEDPWDII70SF AIM MHS021 K3 1116 FDA UDI
- Model / Reference
- ARDPWT239192A EUDAMEDFDA UDI
- Description
- PWDII70SF AIM MHS021 K3 1116 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712409012 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700712421298RT EUDAMED
- Direct Marketing DI
- 03700712409012 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Operating room light system
Introducing the Maquet PowerLED II, a cutting-edge medical device designed for precise and pain-free treatment of various conditions. With its innovative technology and advanced features, this device is poised to revolutionize the field of medicine.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 47e65430-cc01-45b3-b90f-ddd7a3ba25da 61 fields · synced Jul 12, 2026
- FDA UDI 509fe4fe-2971-43b3-a2db-75f3719a2024 35 fields · synced May 30, 2026