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Loop Electrode, 20mm x 15mm, Ø2.4mm Shaft, 15 cm Length, Single Use, Sterile
EUDAMEDClass IIb (EU MDR)
Ref CL-021-2015S
Identity
- Trade Name
- Loop Electrode, 20mm x 15mm, Ø2.4mm Shaft, 15 cm Length, Single Use, Sterile EUDAMED
- Device Name
- Loop Electrode, 20mm x 15mm, Ø2.4mm Shaft, 15 cm Length, Single Use, Sterile EUDAMED
- Model / Reference
- CL-021-2015S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103596819 EUDAMED
- Basic UDI-DI
- B-08961103596819 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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: Open-surgery electrosurgical electrode, monopolar, single-use
Loop Electrode, 20mm x 15mm, Ø2.4mm Shaft, 15 cm Length, Single Use, Sterile by The Surge International — Class IIb — MDD — listed in EUDAMED
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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-08961103596819 | Class IIb | Active |
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Manufacturer
- Manufacturer
- The Surge International
- EUDAMED SRN
- PK-MF-000043013
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED a08d7a64-ed47-43d3-95e3-a9ca8af159e9 61 fields · synced Jul 21, 2026