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Tropian
EUDAMEDClass IIa (EU MDR)
Ref ZT-22FRef ZT-10TRef ZT-10Ref ZT-30TRef ZT-20TRef ZT-40Ref ZT-30Ref ZT-40TRef ZTC-40
Identity
- Trade Name
- Tropian EUDAMED
- Device Name
- laparoscopy Trocar EUDAMED
- Model / Reference
- ZT-22F EUDAMEDZT-10T EUDAMEDZT-10 EUDAMEDZT-30T EUDAMEDZT-20T EUDAMEDZT-40 EUDAMEDZT-30 EUDAMEDZT-40T EUDAMEDZTC-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809417426869 EUDAMED08809417426821 EUDAMED08809417426814 EUDAMED08809417426883 EUDAMED08809417426852 EUDAMED08809417426890 EUDAMED08809417426876 EUDAMED08809417426906 EUDAMED08809417426937 EUDAMED
- Basic UDI-DI
- B-08809417426869 EUDAMEDB-08809417426821 EUDAMEDB-08809417426814 EUDAMEDB-08809417426883 EUDAMEDB-08809417426852 EUDAMEDB-08809417426890 EUDAMEDB-08809417426876 EUDAMEDB-08809417426906 EUDAMEDB-08809417426937 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-08809417426869 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zerone Co., Ltd.
- EUDAMED SRN
- KR-MF-000014148
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (9)
- EUDAMED 7a00f02b-6da0-4eda-b14d-fe5101337bb6 61 fields · synced Aug 2, 2026
- EUDAMED a7cfb7e2-f85f-4657-b916-ee97b09ffead 61 fields · synced May 16, 2026
- EUDAMED ae29b76e-4a00-4f4e-a7e9-f1d3577f6488 61 fields · synced May 16, 2026
- EUDAMED 2a97379f-40e3-4a16-8317-73a3e04000eb 61 fields · synced May 16, 2026
- EUDAMED 86ae6417-a8e0-4cb8-b27a-bea0f40e18cb 61 fields · synced May 17, 2026
- EUDAMED 54a08476-0a1c-434f-9c90-80a38404c980 61 fields · synced May 17, 2026
- EUDAMED 97f0335a-db5c-4089-be88-dbd65e06b143 61 fields · synced May 17, 2026
- EUDAMED fd4d7e2c-3ffb-4442-bfdf-f8b98dc9d3d8 61 fields · synced May 17, 2026
- EUDAMED 94c936cf-ec1c-4998-8145-b948b5f7276f 61 fields · synced May 19, 2026