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MANI OPHTHALMIC KNIFE - Slit-Angled 1.2mm SK
EUDAMEDClass IIa (EU MDR)
Ref MSL12SK
by Mani, Inc.
Identity
- Trade Name
- MANI OPHTHALMIC KNIFE - Slit-Angled 1.2mm SK EUDAMED
- Device Name
- MANI OPHTHALMIC KNIFE EUDAMED
- Model / Reference
- MSL12SK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951404048 EUDAMED
- Basic UDI-DI
- B-04546951404048 EUDAMED4546951000011ZC 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
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 - Slit-Angled 1.2mm SK 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-04546951404048 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951404048 | 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 17759b28-5037-4c57-a221-a414086e0967 61 fields · synced Jul 17, 2026
- EUDAMED ecab3ad2-cc6f-40f3-8f7f-cac080ab874e 61 fields · synced May 19, 2026