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MANI OPHTHALMIC KNIFE - Guard Knife LRI 600μm
EUDAMEDClass IIa (EU MDR)
Ref MLR60 Ref MLR60
by Mani, Inc.
Identity
- Trade Name
- MANI OPHTHALMIC KNIFE - Guard Knife LRI 600μm EUDAMED
- Device Name
- MANI OPHTHALMIC KNIFE EUDAMED
- Model / Reference
- MLR60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951403935 EUDAMED
- Basic UDI-DI
- B-04546951403935 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 600μm 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-04546951403935 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951403935 | 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 c23a2fac-579a-4e40-b941-fcabe7c0334a 61 fields · synced Jul 28, 2026
- EUDAMED 4df37eb9-a841-4f9a-ae2e-6a27e2879f78 61 fields · synced May 17, 2026