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Thermage Marking Paper, 16.00cm2
EUDAMEDFDA UDIClass I (EU MDR)
Ref SM-16.00Model Thermage FLX
Identity
- Trade Name
- THERMAGE MARKING PAPER, 16.00CM2 EUDAMEDTHERMAGE FLX FDA UDI
- Generic Name
- Skin marking transfer paper FDA UDI
- Device Name
- FOOTSWITCH EUDAMEDGRID, SKIN MARKING, 16.00 SQUARE CM FDA UDI
- Model / Reference
- Thermage FLX EUDAMEDSM-16.00 EUDAMEDFDA UDI
- Description
- GRID, SKIN MARKING, 16.00 SQUARE CM FDA UDI
Identifiers
- Catalog Number
- SM-16.00 FDA UDI
- Primary DI / UDI-DI
- 00816995021339 EUDAMEDFDA UDI
- Basic UDI-DI
- 081699502B0014WD EUDAMED
- FDA Product Code
- ISA FDA UDIGEI FDA UDI
- EMDN Code
- Z12040203 DERMAL REGENERATION EQUIPMENT EUDAMED
- GMDN Term
- Skin marking transfer paper FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5660 FDA UDI878.4400 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Thermage Marking Paper, 16.00cm2 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 | 081699502B0014WD | 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 7a31031b-1d89-429c-b970-f61d1fe84b7e 61 fields · synced Jun 19, 2026
- FDA UDI 9e483842-e84b-483d-988c-5f64f3f65284 34 fields · synced May 30, 2026