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Sterile single use active electrodes
EUDAMEDClass IIb (EU MDR)
Ref EN495-FG28266
Identity
- Device Name
- Sterile single use active electrodes EUDAMED
- Model / Reference
- EN495-FG28266 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939029816245 EUDAMED
- Basic UDI-DI
- B-06939029816245 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Sterile single use active electrodes by Modern Medical Equipment Manufacturing, Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06939029816245 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Modern Medical Equipment Manufacturing Ltd.
- EUDAMED SRN
- HK-MF-000001781
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 1ba84e87-a0e8-45b5-804a-742dcc863780 61 fields · synced Aug 4, 2026