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Polaris 600
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref G16720Model 103024XK19Z000Ref GG16100Model 103032XK19Z000
Identity
- Trade Name
- Polaris 600 System EUDAMEDPolaris EUDAMEDPolaris 600 FDA UDI
- Generic Name
- Operating room light FDA UDI
- Model / Reference
- G16720 EUDAMEDFDA UDI103024XK19Z000 EUDAMED103032XK19Z000 EUDAMEDGG16100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675416562 EUDAMEDFDA UDI04048675754947 EUDAMED
- Basic UDI-DI
- 040486751103024XK19Z00072 EUDAMED040486751103032XK19Z0006H EUDAMED
- Direct Marketing DI
- 04048675416562 EUDAMED04048675754947 EUDAMED
- FDA Product Code
- FTD FDA UDI
- EMDN Code
- Z12010701,Z12010702 EUDAMEDZ12010701 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
- Germany 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
Category: Operating room light
Polaris 600 by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Operating room light.
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- HarmonyAIR — STERIS CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (3)
- FDA UDI 6a0a65cb-fc42-4b17-bcb1-52fca8470f65 33 fields · synced Jul 15, 2026
- EUDAMED 6a544def-d4cd-4bb3-8d98-ee7bd4b5a714 61 fields · synced Jul 15, 2026
- EUDAMED 32c021a2-8162-4bb3-9bc7-1ce0997cb7c8 61 fields · synced Jul 15, 2026