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MANI OPHTHALMIC KNIFE - Slit-Angled 2.2mm SK
EUDAMEDClass IIa (EU MDR)
Ref MSL22SK
by Mani, Inc.
Identity
- Trade Name
- MANI OPHTHALMIC KNIFE - Slit-Angled 2.2mm SK EUDAMED
- Device Name
- MANI OPHTHALMIC KNIFE EUDAMED
- Model / Reference
- MSL22SK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951404086 EUDAMED
- Basic UDI-DI
- 4546951000011ZC EUDAMEDB-04546951404086 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
MANI OPHTHALMIC KNIFE - Slit-Angled 2.2mm SK by Mani, Inc. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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 79a61c8f-c8d7-4665-b822-8bd9011c01ce 61 fields · synced Jul 29, 2026
- EUDAMED fae52604-d181-4c76-bbca-538b63397f31 61 fields · synced May 19, 2026