Identity
- Trade Name
- 810nm/1000mW Infra-red laser cluster. EUDAMED
- Device Name
- 810nm/1000mW Infra-red laser cluster. EUDAMED
- Model / Reference
- S2160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060494130152 EUDAMED
- Basic UDI-DI
- B-05060494130152 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Red-light phototherapy unit, professional
810nm/1000mW Infra-red laser cluster. by THOR Photomedicine Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Red-light phototherapy unit, professional.
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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-05060494130152 | Class IIb | Active |
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Manufacturer
- Manufacturer
- THOR Photomedicine Ltd
- EUDAMED SRN
- UK-MF-000039048
- Authorised Representative
- THOR Photomedicine EU Limited IE-AR-000031669
Sources (1)
- EUDAMED 39c85a4d-31fe-4631-8c0d-14b427cc8629 61 fields · synced Jul 27, 2026