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Electrosurgical Unit
EUDAMEDClass IIb (EU MDR)
Ref ZEUS PRIMERef ACE-200Ref ZEUS-100Ref DOCTANZ300Ref ZEUS-300Ref ACE-150Ref DOCTANZ200SRef ZEUS-150Ref DOCTANZ100Ref ACE-300Ref ACE-100Ref SENS-ZRef DOCTANZ TOUCH
Identity
- Trade Name
- Electrosurgical Unit EUDAMED
- Device Name
- Electrosurgical Unit EUDAMED
- Model / Reference
- ZEUS PRIME EUDAMEDACE-200 EUDAMEDZEUS-100 EUDAMEDDOCTANZ300 EUDAMEDZEUS-300 EUDAMEDACE-150 EUDAMEDDOCTANZ200S EUDAMEDZEUS-150 EUDAMEDDOCTANZ100 EUDAMEDACE-300 EUDAMEDACE-100 EUDAMEDSENS-Z EUDAMEDDOCTANZ TOUCH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809417420317 EUDAMED08809417420065 EUDAMED08809417420287 EUDAMED08809417420263 EUDAMED08809417420256 EUDAMED08809417420096 EUDAMED08809417420140 EUDAMED08809417420072 EUDAMED08809417420294 EUDAMED08809417420270 EUDAMED08809417420300 EUDAMED08809417420232 EUDAMED08809417420171 EUDAMED
- Basic UDI-DI
- B-08809417420317 EUDAMEDB-08809417420065 EUDAMEDB-08809417420287 EUDAMEDB-08809417420263 EUDAMEDB-08809417420256 EUDAMEDB-08809417420096 EUDAMEDB-08809417420140 EUDAMEDB-08809417420072 EUDAMEDB-08809417420294 EUDAMEDB-08809417420270 EUDAMEDB-08809417420300 EUDAMEDB-08809417420232 EUDAMEDB-08809417420171 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Foot-switch, electrical
Electrosurgical Unit by Zerone Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08809417420317 | Class IIb | 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 (13)
- EUDAMED 8df77633-406d-4ffb-8927-fb6f61493c16 61 fields · synced Jul 26, 2026
- EUDAMED 964f8177-40aa-41e8-a97d-8586eed65fc1 61 fields · synced May 16, 2026
- EUDAMED 5bc7498f-3d46-4b18-b013-35294f309861 61 fields · synced May 16, 2026
- EUDAMED 6cf76410-375a-4021-80a2-eaa9828a1e1c 61 fields · synced May 16, 2026
- EUDAMED c44cfe98-86b5-4271-acea-4fd5d30cfb5f 61 fields · synced May 16, 2026
- EUDAMED 09f93944-417a-4a4b-994a-1851e8a8f322 61 fields · synced May 17, 2026
- EUDAMED 2ee28a2a-86f0-4cd1-8e2d-91916ca2e6b1 61 fields · synced May 17, 2026
- EUDAMED 10123079-55f5-40a0-a16a-c3cff1e8eeb6 61 fields · synced May 17, 2026
- EUDAMED b80cdf05-5139-4133-b251-7a289e30e1a9 61 fields · synced May 17, 2026
- EUDAMED 02aa87cd-69fa-44af-9d9e-44149fa9fa3f 61 fields · synced May 17, 2026
- EUDAMED b454a5c7-ac3c-4c9d-b369-0487dbd01b9f 61 fields · synced May 18, 2026
- EUDAMED 78c31fd6-ee0f-4063-8e4c-a7522f454dff 61 fields · synced May 19, 2026
- EUDAMED 5ef7d655-3cbc-4f0e-b29d-4177035c45ee 61 fields · synced May 19, 2026