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MANI INFUSION CANNULA - Infusion Cannula 27G S
EUDAMEDClass IIa (EU MDR)
Ref MIC27S
by Mani, Inc.
Identity
- Trade Name
- MANI INFUSION CANNULA - Infusion Cannula 27G S EUDAMED
- Device Name
- MANI TROCAR KIT EUDAMED
- Model / Reference
- MIC27S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951405748 EUDAMED
- Basic UDI-DI
- 4546951000022ZH EUDAMEDB-04546951405748 EUDAMED
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE 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
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
MANI INFUSION CANNULA - Infusion Cannula 27G S by Mani, Inc. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
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 | 4546951000022ZH | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4546951000022ZH | 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 266c4e65-96b9-46d7-82b7-459e0540bf1e 61 fields · synced Jul 16, 2026
- EUDAMED b8c2f4d3-495f-44dc-aaef-7b5224db9e30 61 fields · synced May 19, 2026