Identity
- Trade Name
- Wire loop electrode, 8mm, handle 1.6mm EUDAMED
- Device Name
- MONOPOLAR ELECTRODE, NON-STERILE EUDAMED
- Model / Reference
- 540-600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907763292053 EUDAMED
- Basic UDI-DI
- 59077632-TF14MONO-ELEC-7D EUDAMED
- EMDN Code
- L180601 OPEN ELECTROSURGERY ELECTRODES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wire loop electrode, 8mm, handle 1.6mm by Emed Sp. Z O. O. Sp. K. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 59077632-TF14MONO-ELEC-7D | Class IIb | Active |
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Manufacturer
- Manufacturer
- Emed Sp. Z O. O. Sp. K.
- EUDAMED SRN
- PL-MF-000012648
Sources (1)
- EUDAMED 4aa404d3-c31b-41e1-8adf-58b3ad5d94d6 61 fields · synced Jun 19, 2026