Identity
- Trade Name
- NIR Acutip Laser EUDAMED
- Device Name
- LX2.3 EUDAMED
- Model / Reference
- S2090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060494130664 EUDAMED
- Basic UDI-DI
- 506049413LX2SYSTEMJW EUDAMED
- Direct Marketing DI
- 05060494130664 EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Red-light phototherapy unit, professional
NIR Acutip Laser by THOR Photomedicine Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Red-light phototherapy unit, professional.
- Lumie Brazil — Outside In (Cambridge) Ltd trading as Lumie · Class IIa
- Controller Unit (CU+) — MEDI-TECH INTERNATIONAL CORPORATION · Class II
- PRO WELLNESS — PHOTON 4 HEALTH B.V. · Class I
- Shark cryoglow — SharkNinja Operating LLC · Class IIa
- Bodyclock Luxe 700FM — Outside In (Cambridge) Ltd trading as Lumie · Class I
- BASIC MIND WELLNESS SYSTEM® — PHOTON 4 HEALTH B.V. · Class I
- Ströme Energy+ — Zero-Plus International Limited · Class IIa
- HYDRO 4 HEALTH® LASER ATP WRISTBAND — PHOTON 4 HEALTH B.V. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506049413LX2SYSTEMJW | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- THOR Photomedicine Ltd
- EUDAMED SRN
- UK-MF-000039048
- Authorised Representative
- THOR Photomedicine EU Limited IE-AR-000031669
Sources (1)
- EUDAMED 883eaac0-1be6-45aa-8bb5-7e05aa548514 61 fields · synced Jun 18, 2026