Identity
- Trade Name
- Überlube EUDAMEDFDA UDI
- Generic Name
- Sexual lubricant FDA UDI
- Device Name
- Überlube EUDAMED50ml Bottle FDA UDI
- Model / Reference
- UBER-50 EUDAMEDFDA UDI
- Description
- 50ml Bottle FDA UDI
Identifiers
- Catalog Number
- UBER-50 FDA UDI
- Primary DI / UDI-DI
- 00851674003008 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851674003UBER2010H5 EUDAMED
- Direct Marketing DI
- 00851674003008 EUDAMED
- 510(k) Number
- K151647 FDA UDI
- FDA Product Code
- NUC FDA UDI
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
- GMDN Term
- Sexual lubricant FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.5300 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Überlube by Uberlube — Class IIb — 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 | 0851674003UBER2010H5 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Uberlube
- EUDAMED SRN
- US-MF-000042325
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 89cb09e8-41cc-465f-9ad0-97980bdf2dc1 61 fields · synced Jul 18, 2026
- FDA UDI 6f8d2284-b3c9-4abf-b42c-c94e67478f95 35 fields · synced May 30, 2026