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MANI OPHTHALMIC KNIFE - Universal Bevel Up 0.8mm
EUDAMEDClass IIa (EU MDR)
Ref MUN08
by Mani, Inc.
Identity
- Trade Name
- MANI OPHTHALMIC KNIFE - Universal Bevel Up 0.8mm EUDAMED
- Device Name
- MANI OPHTHALMIC KNIFE EUDAMED
- Model / Reference
- MUN08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951604080 EUDAMED
- Basic UDI-DI
- B-04546951604080 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 - Universal Bevel Up 0.8mm 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 | B-04546951604080 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-04546951604080 | 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 8882bb2c-dbb4-4f1c-a224-79a0ea9896e3 61 fields · synced Jul 24, 2026
- EUDAMED 8882bb2c-dbb4-4f1c-a224-79a0ea9896e3 61 fields · synced May 19, 2026