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Electrosurgical units (ESU) for general use
EUDAMEDClass IIb (EU MDR)
Ref RD-General-Dm-0002-08Model Meg1
Identity
- Device Name
- Electrosurgical units (ESU) for general use EUDAMED
- Model / Reference
- Meg1 EUDAMEDRD-General-Dm-0002-08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06260898400014 EUDAMED
- Basic UDI-DI
- B-06260898400014 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden 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 units (ESU) for general use by Kavandish System Engineering Co. — 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-06260898400014 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Kavandish System Engineering Co.
- EUDAMED SRN
- IR-MF-000014010
- Authorised Representative
- Trionara Technologies AB SE-AR-000005045
Sources (1)
- EUDAMED 264e0875-c867-4e19-87aa-2c5ea45b695b 61 fields · synced Jul 10, 2026