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MANI OPHTHALMIC KNIFE - Guard Knife Depth 350μm
EUDAMEDClass IIa (EU MDR)
Ref MDP35Ref MDP35
by Mani, Inc.
Identity
- Trade Name
- MANI OPHTHALMIC KNIFE - Guard Knife Depth 350μm EUDAMED
- Device Name
- MANI OPHTHALMIC KNIFE EUDAMED
- Model / Reference
- MDP35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951404253 EUDAMED
- Basic UDI-DI
- 4546951000011ZC EUDAMEDB-04546951404253 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 - Guard Knife Depth 350μm 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 689da517-6b10-4819-bc1e-f7b3687b591d 61 fields · synced Jun 19, 2026
- EUDAMED 3b2959c9-c078-4828-ac02-a723c8f6e3dc 61 fields · synced May 18, 2026