MANI INFUSION CANNULA - Infusion Cannula 23G S HF
EUDAMEDFDA UDIClass IIa (EU MDR)
by Mani, Inc.
Identity
- Trade Name
- MANI INFUSION CANNULA - Infusion Cannula 23G S HF EUDAMEDMANI INFUSION CANNULA - Infusion Cannula 23G S EUDAMEDMANI Infusion Cannula FDA UDI
- Generic Name
- Ophthalmic cannulation set, single-use FDA UDI
- Device Name
- MANI TROCAR KIT EUDAMEDFDA UDI
- Model / Reference
- MIC23HF EUDAMEDMIC23S EUDAMEDMIC23S Infusion Cannula 23G S FDA UDI
- Description
- MANI Trocar Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951405762 EUDAMED14546951404007 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04546951405762 EUDAMED4546951000022ZH EUDAMED
- Unit of Use DI
- 74546951404009 EUDAMED
- FDA Product Code
- NGY FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic cannulation set, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
MANI INFUSION CANNULA - Infusion Cannula 23G S HF by Mani, Inc. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- 85784S 17GA I/A Handpiece, str., tip 45° angled — Bausch & Lomb GmbH · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04546951405762 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951405762 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED e29b49d7-1740-48e0-b142-b80d365da48f 61 fields · synced Aug 1, 2026
- EUDAMED 19a06e26-ef6f-4aa6-ab4f-5db9079e7d5c 61 fields · synced May 17, 2026
- FDA UDI 6e032e94-c844-48cb-b352-2fe86a398799 33 fields · synced May 30, 2026
- EUDAMED 121f22d7-b33d-47b0-afa7-4bc443b11929 61 fields · synced Aug 1, 2026