Identity
- Trade Name
- EVOLYSSE SMOOTH FDA UDI
- Generic Name
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
- Device Name
- Dermal HA filler for NLF - Sample FDA UDI
- Model / Reference
- EVOF1S001-S FDA UDI
- Description
- Dermal HA filler for NLF - Sample FDA UDI
Identifiers
- Catalog Number
- EVO-SMTH-01-S FDA UDI
- Primary DI / UDI-DI
- 03760172161301 FDA UDI
- PMA Number
- P240022 FDA UDI
- FDA Product Code
- LMH FDA UDI
- GMDN Term
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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
No
FDA UDI
Category: Dermal tissue reconstructive material, microbe-derived, anaesthetic
Evolysse Smooth by Symatese — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dermal tissue reconstructive material, microbe-derived, anaesthetic.
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Cleared under the same submission
P240022 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Symatese
Sources (1)
- FDA UDI 6ff2f65f-e20d-4061-aa50-890db4decc5e 36 fields · synced May 30, 2026