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MANI OPHTHALMIC KNIFE - Straight 15°
EUDAMEDClass IIa (EU MDR)
Ref MST15
by Mani, Inc.
Identity
- Trade Name
- MANI OPHTHALMIC KNIFE - Straight 15° EUDAMED
- Device Name
- MANI OPHTHALMIC KNIFE EUDAMED
- Model / Reference
- MST15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951400057 EUDAMED
- Basic UDI-DI
- 4546951000011ZC EUDAMEDB-04546951400057 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
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 - Straight 15° 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 2a11bbef-ebc8-4bd4-ae14-cf7d02755d8d 61 fields · synced Jun 18, 2026
- EUDAMED bf07085d-8761-4903-8264-8a58771e7874 61 fields · synced May 18, 2026