Disposable Handle Polaris, Single
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Einweghandgriff Polaris, Solo EUDAMEDDisposable Handle Polaris, Single FDA UDI
- Generic Name
- Medical equipment handle cover, single-use FDA UDI
- Model / Reference
- MP05701 EUDAMEDFDA UDIS080426K19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675540120 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751S080426K19Z00062 EUDAMED
- FDA Product Code
- FTA FDA UDI
- EMDN Code
- Z12010785 SCIALYTIC LAMP LIGHTING SYSTEMS - CONSUMABLES EUDAMED
- GMDN Term
- Medical equipment handle cover, single-use 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
Yes
Single Use
Yes
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
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Medical equipment handle cover, single-use
Disposable Handle Polaris, Single by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 (2)
- FDA UDI e6f18de0-763f-46b3-af4c-ab61c0405485 32 fields · synced Sep 17, 2026
- EUDAMED 06ac0a7c-f7c9-46c6-934f-fc3bb38e1960 61 fields · synced Jun 18, 2026