Identity
- Trade Name
- UriCap Female Device FDA UDI
- Generic Name
- Urine transfer IVD, non-sterile FDA UDI
- Device Name
- UriCap Female device EUDAMED
- Model / Reference
- FPR02020L EUDAMEDC FDA UDI
Identifiers
- Catalog Number
- FPR02020L FDA UDI
- Primary DI / UDI-DI
- 07290109270012 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010927FPR02020LQ4 EUDAMED
- Direct Marketing DI
- 07290109270012 EUDAMED
- FDA Product Code
- NZU FDA UDI
- EMDN Code
- A06030399 URINE COLLECTION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Urine transfer IVD, non-sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Market of Registration
- Sweden 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
UriCap Female device by Tilla Care Ltd — 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 | 729010927FPR02020LQ4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tilla Care Ltd.
- EUDAMED SRN
- IL-MF-000016049
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 07b0f1e5-16a2-4554-b89a-e06a3f55fb8a 61 fields · synced Jun 18, 2026
- FDA UDI f9d5c8e3-c5e7-4c20-82ce-ca894d27129d 33 fields · synced May 30, 2026