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HydraFacial
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 7000079-WHT-DIORModel 70000079-BLK
Identity
- Trade Name
- HydraFacial EUDAMEDDior Syndeo FDA UDI
- Generic Name
- Skin abrasion unit FDA UDI
- Device Name
- HydraFacial Syndeo EUDAMED220-240VAC, 50/60Hz, 2A FDA UDI
- Model / Reference
- 70000079-BLK EUDAMED7000079-WHT-DIOR EUDAMED240V, White FDA UDI
- Description
- 220-240VAC, 50/60Hz, 2A FDA UDI
Identifiers
- Catalog Number
- 7000079-WHT-DIOR FDA UDI
- Primary DI / UDI-DI
- 00810007533896 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000753SYNB4 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
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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 | 081000753SYNB4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 90e7699a-98c2-465b-b6fd-59b05debb1bf 61 fields · synced Jun 7, 2026
- FDA UDI d362cab3-8641-470e-aeae-85fceb0a5a1c 35 fields · synced May 30, 2026