Identity
- Trade Name
- Tixel 2 EUDAMEDFDA UDI
- Generic Name
- Thermo-mechanical skin surface treatment system FDA UDI
- Device Name
- Tixel 2 EUDAMED
- Model / Reference
- TXLD0012 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290117520048 EUDAMED07290117524039 FDA UDI
- Basic UDI-DI
- 729011752TXLD0012VD EUDAMED
- Direct Marketing DI
- 07290117520048 EUDAMED
- 510(k) Number
- K223033 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12040203,Z12040218 EUDAMED
- GMDN Term
- Thermo-mechanical skin surface treatment system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Tixel 2 by Novoxel Ltd — Class IIa — 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 | 729011752TXLD0012VD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Novoxel Ltd.
- EUDAMED SRN
- IL-MF-000008897
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED d22ef427-6160-4f31-ae1e-7bd9c631f84a 61 fields · synced Jul 15, 2026
- FDA UDI 62a9c0d5-222c-4c9c-91a4-893bf51fcb3a 33 fields · synced May 30, 2026