Identity
- Trade Name
- SLZ 3XC LED - TOMEY EUDAMED
- Device Name
- Slit Lamp EUDAMED
- Model / Reference
- TSL-4000Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272718370 EUDAMED
- Basic UDI-DI
- 50552727SLITLAMPSRG EUDAMED
- Direct Marketing DI
- 05055272718370 EUDAMED
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMED
Classification
- Device Class
- Class I 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
Slz 3xc Led - Tomey by Keeler Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 50552727SLITLAMPSRG | Class I | Active |
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Manufacturer
- Manufacturer
- Keeler Ltd
- EUDAMED SRN
- GB-MF-000009031
- Authorised Representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
Sources (1)
- EUDAMED a990f095-f357-4172-b167-076cfad91684 61 fields · synced Jul 15, 2026