Identity
- Trade Name
- ERMC EUDAMED
- Device Name
- Single Use Sterile Non Sterile Electrosurgical Electrode with and Without Handle Cautery EUDAMED
- Model / Reference
- ERMC: D601X-301X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964000797044 EUDAMED
- Basic UDI-DI
- B-08964000797044 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Ermc by Electro Range MFG Co — 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-08964000797044 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Electro Range MFG Co
- EUDAMED SRN
- PK-MF-000036519
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 0dee8c04-1605-4bf6-bca8-d56068b8c045 61 fields · synced Jun 19, 2026