Identity
- Trade Name
- HydraFacial EUDAMEDHydrafacial™ Lip Tip FDA UDI
- Generic Name
- Skin abrasion unit FDA UDI
- Device Name
- HydroPeel Tip, Large Clear EUDAMEDHydrafacial™ Lip Tip FDA UDI
- Model / Reference
- 74111 EUDAMED7200225 EUDAMEDHydrafacial™ Lip Tip FDA UDI
- Description
- Hydrafacial™ Lip Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810007534756 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000753TIP9V EUDAMED
- FDA Product Code
- GFE FDA UDI
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Skin abrasion unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dermatological laser beam guiding handpiece
HydraFacial by Hydrafacial LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 081000753TIP9V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hydrafacial, LLC
- EUDAMED SRN
- US-MF-000004431
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 2dfe9b7d-b43c-4d14-aad5-bf36ad663e7b 61 fields · synced Jul 16, 2026
- FDA UDI 41460c96-36ee-438e-8af0-68f296adc1fa 33 fields · synced May 30, 2026