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Thermage Marking Paper, 16cm2
EUDAMEDFDA UDIClass I (EU MDR)
Ref TK-16.00Model Thermage
Identity
- Trade Name
- THERMAGE MARKING PAPER, 16CM2 EUDAMEDThermage FDA UDI
- Generic Name
- Skin marking transfer paper FDA UDI
- Device Name
- Cryogen Canister EUDAMEDSKIN MARKING GRID, 16.00CM2 FDA UDI
- Model / Reference
- Thermage EUDAMEDTK-16.00 EUDAMEDFDA UDI
- Description
- SKIN MARKING GRID, 16.00CM2 FDA UDI
Identifiers
- Catalog Number
- TK-16.00 FDA UDI
- Primary DI / UDI-DI
- 00850608002216 EUDAMEDFDA UDI
- Basic UDI-DI
- 081699502B0001W4 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, 16cm2 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 effb4357-820f-461c-a456-4839b063d3e1 61 fields · synced Jun 19, 2026
- FDA UDI f7d051af-7e7d-40fd-aa55-8f399ddfc620 34 fields · synced May 30, 2026