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Mani Trocar Kit - Trocar Kit 25g S
EUDAMEDClass IIa (EU MDR)
Ref MTK25SRef MTK25S
by Mani, Inc.
Identity
- Trade Name
- MANI TROCAR KIT - TROCAR KIT 25G S EUDAMED
- Device Name
- MANI TROCAR KIT EUDAMED
- Model / Reference
- MTK25S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951403959 EUDAMED
- Basic UDI-DI
- 4546951000012ZE EUDAMEDB-04546951403959 EUDAMED
- EMDN Code
- Q021113 OPHTHALMIC SURGERY INSTRUMENT KITS, 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
Mani Trocar Kit - Trocar Kit 25g 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 | 4546951000012ZE | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4546951000012ZE | 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 ee3c0bf5-3f30-46b0-9d7d-a6aa6cefb60a 61 fields · synced Jul 9, 2026
- EUDAMED 8cf501bc-8ef6-4e76-822f-6a4780f44c9d 61 fields · synced May 17, 2026