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Überlube
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref UBER-FOILRef UBER-15SRef UBER-30RF
by Uberlube
Identity
- Trade Name
- Überlube EUDAMEDFDA UDI
- Generic Name
- Sexual lubricant FDA UDI
- Device Name
- Überlube EUDAMEDFoil Pack FDA UDIGood-to-Go Refills FDA UDIGood-to-Go Silver FDA UDI
- Model / Reference
- UBER-FOIL EUDAMEDFDA UDIUBER-30RF EUDAMEDFDA UDIUBER-15S EUDAMEDFDA UDI
- Description
- Foil Pack FDA UDIGood-to-Go Refills FDA UDIGood-to-Go Silver FDA UDI
Identifiers
- Catalog Number
- UBER-FOIL FDA UDIUBER-30RF FDA UDIUBER-15S FDA UDI
- Primary DI / UDI-DI
- 00851674003084 EUDAMEDFDA UDI00851674003053 EUDAMEDFDA UDI00851674003039 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851674003UBER2010H5 EUDAMED
- Direct Marketing DI
- 00851674003084 EUDAMED00851674003039 EUDAMED00851674003053 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 (6)
- EUDAMED 13e045c8-99df-404b-8128-830e1859f293 61 fields · synced Jul 16, 2026
- FDA UDI 71b30058-4e52-489d-9623-2dc3ae7b19f4 35 fields · synced May 30, 2026
- FDA UDI 2f1d7ddd-1eef-476c-8960-1842c8400439 35 fields · synced May 30, 2026
- FDA UDI abdf120c-7873-4d3b-bbde-0ffa78b820a1 35 fields · synced May 30, 2026
- EUDAMED 4965aa93-bef7-4362-bc83-02614fd50e45 61 fields · synced Jul 15, 2026
- EUDAMED 5d1206be-7c12-434d-9bf2-be0c9bf49704 61 fields · synced Jul 16, 2026