Identity
- Trade Name
- MANI TROCAR - Trocar 27G S EUDAMED
- Device Name
- MANI TROCAR KIT EUDAMED
- Model / Reference
- MTR27S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951405731 EUDAMED
- Basic UDI-DI
- 4546951000021ZF EUDAMEDB-04546951405731 EUDAMED
- EMDN Code
- Q020199 OPHTHALMIC CUTTING DEVICES - OTHER 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 TROCAR - Trocar 27G S 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 | 4546951000021ZF | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4546951000021ZF | 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 d33d5bf7-6fe1-4990-8b31-d3c15544f3f1 61 fields · synced Jul 29, 2026
- EUDAMED 53022b40-10ce-43f4-be4a-ce7ce23fe067 61 fields · synced May 19, 2026