Identity
- Trade Name
- Ultrasonic Surgical Unit EUDAMED
- Device Name
- Ultrasonic Surgical Unit EUDAMED
- Model / Reference
- ULTRA-Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809417421017 EUDAMED
- Basic UDI-DI
- B-08809417421017 EUDAMED
- EMDN Code
- Z12010801 ULTRASONIC SCALPEL 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
Ultrasonic Surgical Unit by Zerone Co., Ltd. — Class IIb — 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-08809417421017 | Class IIb | 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 790173b2-5db9-41a5-a349-90a008e7fd80 61 fields · synced Jun 18, 2026