Identity
- Trade Name
- EVOLYSSE FORM FDA UDI
- Generic Name
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
- Device Name
- Dermal HA filler for NLF - Demo FDA UDI
- Model / Reference
- EVOF1F001-D FDA UDI
- Description
- Dermal HA filler for NLF - Demo FDA UDI
Identifiers
- Catalog Number
- EVO-FRM-01-D FDA UDI
- Primary DI / UDI-DI
- 03760172161295 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 Form by Symatese — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 ff9c50cc-561f-4c9f-88d2-7513413dc940 35 fields · synced Jun 8, 2026