Identity
- Trade Name
- QuickChange EUDAMEDQuickChange, 35 Count Pack FDA UDI
- Generic Name
- Incontinence pants liner FDA UDI
- Device Name
- QuickChange, 35 Count Pack EUDAMEDQuickChange for Male Incontinence, 35 Count Pack FDA UDI
- Model / Reference
- V 2.0 EUDAMEDFDA UDI35 count pack EUDAMED
- Description
- QuickChange for Male Incontinence, 35 Count Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861859000401 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00861859000401 EUDAMED
- FDA Product Code
- EYQ FDA UDI
- EMDN Code
- T04010299 ABSORBENT UNDERPADS - OTHER EUDAMED
- GMDN Term
- Incontinence pants liner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5920 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
QuickChange by Ui Medical, LLC — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00861859000401 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- UI Medical, LLC
- EUDAMED SRN
- US-MF-000037697
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (2)
- EUDAMED 98fb174c-9a4b-4353-8cd2-9aa83f0ddf5d 61 fields · synced Jun 18, 2026
- FDA UDI a480b1dc-cfe3-4ba7-bf6b-258f56a268ec 34 fields · synced May 30, 2026