Identity
- Trade Name
- SLT EUDAMED
- Device Name
- Binocular Loupes EUDAMED
- Model / Reference
- 50T-4046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945095545699 EUDAMED
- Basic UDI-DI
- 69450955binocularloupesYV EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Slt by Zumax Medical Co., 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 | 69450955binocularloupesYV | Class I | Active |
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Manufacturer
- Manufacturer
- Zumax Medical CO., LTD.
- EUDAMED SRN
- CN-MF-000011126
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 0e78e289-f402-4110-9d13-8ed1daecdfee 61 fields · synced Sep 18, 2026