Identity
- Trade Name
- Disposable Electrosurgical Pencil EUDAMED
- Device Name
- Disposable Electrosurgical Pencil EUDAMED
- Model / Reference
- Dena EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06262298000085 EUDAMED
- Basic UDI-DI
- B-06262298000085 EUDAMED
- EMDN Code
- Z12010985 ELECTROSURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb 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: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Disposable Electrosurgical Pencil by Dadeh Gostaran Dena — 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-06262298000085 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dadeh Gostaran Dena
- EUDAMED SRN
- IR-MF-000038532
- Authorised Representative
- Eska Diagnostics Kft HU-AR-000037211
Sources (1)
- EUDAMED 727168eb-d430-47c0-83c4-9a8b2415a07b 61 fields · synced Jul 23, 2026