Identity
- Device Name
- 12mm Loop Electrode EUDAMED
- Model / Reference
- AE-C03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964001251262 EUDAMED
- Basic UDI-DI
- 89611025702010SV EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
12mm Loop Electrode by Electro Bismed Instruments — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: SINGLE USE LOOP ELECTRODE
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 | 89611025702010SV | Class IIb | Active |
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Manufacturer
- Manufacturer
- Electro Bismed Instruments
- EUDAMED SRN
- PK-MF-000013440
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 83787529-a026-4543-a58e-639ee7774c84 61 fields · synced Jun 17, 2026