Identity
- Trade Name
- MultiPulse TFL EUDAMED
- Device Name
- MultiPulse TFL EUDAMED
- Model / Reference
- J19-8000-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058784002655 EUDAMED
- Basic UDI-DI
- 4058784J198XQP EUDAMED
- Direct Marketing DI
- 04058784002655 EUDAMED
- EMDN Code
- Z12011006 DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
MultiPulse TFL by Asclepion Laser Technologies GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253100 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 4058784J198XQP | Class IIb | Active |
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Manufacturer
- Manufacturer
- Asclepion Laser Technologies GmbH
- EUDAMED SRN
- DE-MF-000005158
Sources (2)
- EUDAMED 17d7f964-0659-4607-add0-c0d625c811b6 61 fields · synced Jun 19, 2026
- FDA 510(k) K253100 1 fields · synced May 18, 2026