Identity
- Trade Name
- L250399 EUDAMED
- Device Name
- Skin Port White Disk, 8PK EUDAMED
- Model / Reference
- 115-0005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816995026242 EUDAMED
- Basic UDI-DI
- B-00816995026242 EUDAMED
- EMDN Code
- L250399 LIPOSUCTION INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ultrasonic surgical system generator
L250399 by Solta Medical, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00816995026242 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Solta Medical, Inc.
- EUDAMED SRN
- US-MF-000018343
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 49d8b599-b985-4382-b4bc-197d78298992 61 fields · synced Jun 19, 2026