Identity
- Trade Name
- Phototherapy Eye Band Large EUDAMED
- Device Name
- Fixation Holders and Bands EUDAMED
- Model / Reference
- DLM-2003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682835110080 EUDAMED
- Basic UDI-DI
- 868283511SINIF1D2J EUDAMED
- EMDN Code
- V0201 PHOTOTHERAPY MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Category: Phototherapy eye protector, reusable
Phototherapy Eye Band Large by Dilamed Tıbbi Ürünler Sanayi ve Ticaret A.Ş. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Phototherapy eye protector, reusable.
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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 | 868283511SINIF1D2J | Class I | Active |
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Manufacturer
- Manufacturer
- Dilamed Tıbbi Ürünler Sanayi ve Ticaret A.Ş.
- EUDAMED SRN
- TR-MF-000025304
Sources (1)
- EUDAMED 223b4dde-6e49-4bd9-a15e-1e370358c170 61 fields · synced Jul 24, 2026