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MANI OPHTHALMIC KNIFE - Guard Knife LRI 550μm
EUDAMEDClass IIa (EU MDR)
Ref MLR55
by Mani, Inc.
Identity
- Trade Name
- MANI OPHTHALMIC KNIFE - Guard Knife LRI 550μm EUDAMED
- Device Name
- MANI OPHTHALMIC KNIFE EUDAMED
- Model / Reference
- MLR55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951403928 EUDAMED
- Basic UDI-DI
- B-04546951403928 EUDAMED4546951000011ZC EUDAMED
- EMDN Code
- Q02010101 OPHTHALMIC MICROKNIVES, STRAIGHT 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
No
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
MANI OPHTHALMIC KNIFE - Guard Knife LRI 550μm by Mani, Inc. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04546951403928 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951403928 | 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 d8a70f43-4bdb-4a9c-807c-252b0ef739fa 61 fields · synced Jul 11, 2026
- EUDAMED b065610d-d2fc-481b-bae4-4613c64bd949 61 fields · synced May 19, 2026