Identity
- Model / Reference
- TL20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-BE-TL20MV EUDAMED
- Basic UDI-DI
- B-BE-TL20MV EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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: Red-light phototherapy unit, professional
Tl20 by Zero-Plus International Limited — Class IIa — 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-BE-TL20MV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zero-Plus International Limited
- EUDAMED SRN
- HK-MF-000018103
- Authorised Representative
- Globalmind consumer electronics GmbH DE-AR-000014256
Sources (1)
- EUDAMED 9358d0ba-bd37-43b1-9173-c0e998a61975 61 fields · synced Jul 10, 2026