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ARGON Electrosurgical Units (ESU)
EUDAMEDClass IIb (EU MDR)
Ref RD-General-Dm-0002Model Iconic Image1Ref RD-General-Dm-0002-08Model Iconic IS410SModel Iconic IS410
Identity
- Device Name
- ARGON Electrosurgical Units (ESU) EUDAMED
- Model / Reference
- Iconic Image1 EUDAMEDRD-General-Dm-0002 EUDAMEDIconic IS410S EUDAMEDRD-General-Dm-0002-08 EUDAMEDIconic IS410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06260898422115 EUDAMED06260898400090 EUDAMED06260898400106 EUDAMED
- Basic UDI-DI
- B-06260898422115 EUDAMEDB-06260898400090 EUDAMEDB-06260898400106 EUDAMED
- EMDN Code
- Z12010903 ARGON ELECTROSURGICAL UNITS (ESU) 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
ARGON Electrosurgical Units (ESU) by Kavandish System Engineering Co. — 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-06260898422115 | 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 (3)
- EUDAMED 79d4a4c2-9e53-4340-b954-ee47b9d5e923 61 fields · synced Jul 19, 2026
- EUDAMED dec11834-6d19-44dd-a9ca-31b5c213c245 61 fields · synced May 17, 2026
- EUDAMED 4e15b5ef-077b-4461-8c2c-600a6b10f069 61 fields · synced May 18, 2026