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Thermage Coupling Fluid, 30ml
EUDAMEDFDA UDIClass I (EU MDR)
Ref TF-2-30Model Thermage
Identity
- Trade Name
- THERMAGE COUPLING FLUID, 30ML EUDAMEDThermage FDA UDI
- Generic Name
- Radio-frequency skin/body contouring system FDA UDI
- Device Name
- Cryogen Canister EUDAMEDCOUPLING FLUID, 30ML FDA UDI
- Model / Reference
- Thermage EUDAMEDTF-2-30 EUDAMEDFDA UDI
- Description
- COUPLING FLUID, 30ML FDA UDI
Identifiers
- Catalog Number
- TF-2-30 FDA UDI
- Primary DI / UDI-DI
- 00850608002155 EUDAMEDFDA UDI
- Basic UDI-DI
- 081699502B0001W4 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12040203 DERMAL REGENERATION EQUIPMENT EUDAMED
- GMDN Term
- Radio-frequency skin/body contouring system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Thermage Coupling Fluid, 30ml by Solta Medical, Inc. — Class I — 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 | 081699502B0001W4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Solta Medical, Inc.
- EUDAMED SRN
- US-MF-000018343
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 87575e38-9539-447b-af16-b4c68ee93ec8 61 fields · synced Jun 17, 2026
- FDA UDI 93655393-238c-4ca5-9ff8-fe19eb098750 34 fields · synced May 29, 2026