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MANI INFUSION CANNULA - Infusion Cannula 27G S HF
EUDAMEDClass IIa (EU MDR)
Ref MIC27HF
by Mani, Inc.
Identity
- Trade Name
- MANI INFUSION CANNULA - Infusion Cannula 27G S HF EUDAMED
- Device Name
- MANI TROCAR KIT EUDAMED
- Model / Reference
- MIC27HF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951405786 EUDAMED
- Basic UDI-DI
- B-04546951405786 EUDAMED4546951000022ZH 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
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 INFUSION CANNULA - Infusion Cannula 27G S HF 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-04546951405786 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951405786 | 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 f04ca73c-850e-47fd-acaf-6a4402c4b5d6 61 fields · synced Jul 13, 2026
- EUDAMED 8f2a93e7-b1b4-4977-ab3d-21ff9b729fc6 61 fields · synced May 19, 2026