← Back to catalogue
HydraFacial
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 70290-03-01Model HydraFacial MD Elite
Identity
- Trade Name
- HydraFacial EUDAMEDHydrafacial MD Elite FDA UDI
- Generic Name
- Skin abrasion unit FDA UDI
- Device Name
- HydraFacial MD Elite EUDAMED220-240VAC, 50/60Hz, 8A FDA UDI
- Model / Reference
- HydraFacial MD Elite EUDAMED70290-03-01 EUDAMED240V FDA UDI
- Description
- 220-240VAC, 50/60Hz, 8A FDA UDI
Identifiers
- Catalog Number
- 70290-03-01 FDA UDI
- Primary DI / UDI-DI
- 00810007531311 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000753ELI7D 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 IIa EUDAMEDClass I FDA 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
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
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
Category: Dermatological laser beam guiding handpiece
HydraFacial by Hydrafacial LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological laser beam guiding handpiece.
- GentleYAG 1.5/3MM Delivery System W/DCD — Candela Corporation · Class II
- Clear & Brilliant — Solta Medical, Inc. · Class II
- hydrosun 750 — Hydrosun Medizintechnik GmbH · Class IIa
- GentleYAG 3MM Delivery System W/O DCD — Candela Corporation · Class II
- External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima — Candela Corporation · Class II
- TL 30 — Globalcare Medical Technology Co., Ltd. · Class IIa
- Open — Candela Corporation · Class II
- Nubway — Beijing Nubway S&T Co., Ltd. · Class II
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 | 081000753ELI7D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hydrafacial, LLC
- EUDAMED SRN
- US-MF-000004431
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 9a132758-344b-4825-95ad-7f403226b095 61 fields · synced Jul 8, 2026
- FDA UDI 2fc32fa1-d63e-4e8a-b200-2aa220d597e7 35 fields · synced May 29, 2026