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Argon Plasma Supplier
EUDAMEDClass IIa (EU MDR)
Ref RD-General-Dm-0002Model APS1
Identity
- Device Name
- Argon Plasma Supplier EUDAMED
- Model / Reference
- APS1 EUDAMEDRD-General-Dm-0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06260898400083 EUDAMED
- Basic UDI-DI
- B-06260898400083 EUDAMED
- EMDN Code
- Z12010903 ARGON ELECTROSURGICAL UNITS (ESU) EUDAMED
Classification
- Device Class
- Class IIa 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 Plasma Supplier by Kavandish System Engineering Co. — 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-06260898400083 | Class IIa | 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 be24bc1d-399c-4d4d-a5de-85610e02b67d 61 fields · synced Jul 9, 2026