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MANI OPHTHALMIC KNIFE - Slit-Angled 1.8mm SK
EUDAMEDClass IIa (EU MDR)
Ref MSL18SK
by Mani, Inc.
Identity
- Trade Name
- MANI OPHTHALMIC KNIFE - Slit-Angled 1.8mm SK EUDAMED
- Device Name
- MANI OPHTHALMIC KNIFE EUDAMED
- Model / Reference
- MSL18SK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951404062 EUDAMED
- Basic UDI-DI
- 4546951000011ZC EUDAMEDB-04546951404062 EUDAMED
- EMDN Code
- Q02010102 OPHTHALMIC MICROKNIVES, ANGLED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMEDEUDAMED
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
Explore the MANI OPHTHALMIC KNIFE - Slit-Angled 1.8mm SK device, a precision instrument for ophthalmic procedures. This device is designed with safety and effectiveness in mind, featuring advanced sterile and disposable capabilities.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4546951000011ZC | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4546951000011ZC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 35189d03-ff8b-423e-868e-553e291ed8b8 61 fields · synced Jul 24, 2026
- EUDAMED d460bf4b-4ee7-4e1a-831c-a1bbc27d64cc 61 fields · synced May 19, 2026