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MANI OPHTHALMIC KNIFE - R Slit-Angled 5.5mm
EUDAMEDClass IIa (EU MDR)
Ref MRS55Ref MRS55
by Mani, Inc.
Identity
- Trade Name
- MANI OPHTHALMIC KNIFE - R Slit-Angled 5.5mm EUDAMED
- Device Name
- MANI OPHTHALMIC KNIFE EUDAMED
- Model / Reference
- MRS55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951400309 EUDAMED
- Basic UDI-DI
- 4546951000011ZC EUDAMEDB-04546951400309 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 - R Slit-Angled 5.5mm 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 f5ef1e61-1b9c-4010-99cd-077a74e4d2a9 61 fields · synced Jul 26, 2026
- EUDAMED 184ea975-5ff6-4cfc-949f-6caa7a2f3395 61 fields · synced May 19, 2026