Identity
- Trade Name
- Tropian EUDAMED
- Device Name
- laparoscopy Trocar EUDAMED
- Model / Reference
- ZT-12F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809417426838 EUDAMED
- Basic UDI-DI
- B-08809417426838 EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Tropian by Zerone Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809417426838 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zerone Co., Ltd.
- EUDAMED SRN
- KR-MF-000014148
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d72bbce9-4da8-4302-a7c3-fc787e6d488b 61 fields · synced Jun 18, 2026