← Back to catalogue
MANI OPHTHALMIC KNIFE - Slit-Angled 1.6mm
EUDAMEDClass IIa (EU MDR)
Ref MSL16 Ref MSL16
by Mani, Inc.
Identity
- Trade Name
- MANI OPHTHALMIC KNIFE - Slit-Angled 1.6mm EUDAMED
- Device Name
- MANI OPHTHALMIC KNIFE EUDAMED
- Model / Reference
- MSL16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951400095 EUDAMED
- Basic UDI-DI
- B-04546951400095 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 1.6mm 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-04546951400095 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951400095 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED edaffb49-1d4f-40db-9563-a3a3c36101cc 61 fields · synced Jul 26, 2026
- EUDAMED 15ba3826-4ec1-4db0-ba84-969a5a5d835a 61 fields · synced May 19, 2026