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Resectoscope Electrode, Ball Type, 3 mm for Olympus 24 Ch
EUDAMEDClass IIb (EU MDR)
Ref ME-ORK3 (M-OB-24F-12L)Model HF Electrodes_ME-ORK3 A [Monopolar Electrode variant (M-OB-24F-12L)]
Identity
- Trade Name
- Resectoscope Electrode, Ball Type, 3 mm for Olympus 24 Ch EUDAMED
- Device Name
- Monopolar Ø3 mm Ball Electrode, 24 Fr, 30°, Compatible with Olympus Brand Resectoscope EUDAMED
- Model / Reference
- HF Electrodes_ME-ORK3 A [Monopolar Electrode variant (M-OB-24F-12L)] EUDAMEDME-ORK3 (M-OB-24F-12L) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904148108425 EUDAMED
- Basic UDI-DI
- B-08904148108425 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Resectoscope Electrode, Ball Type, 3 mm for Olympus 24 Ch by Ace Medical Devices Pvt 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-08904148108425 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ace Medical Devices Pvt Ltd
- EUDAMED SRN
- IN-MF-000023786
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 80f7c562-f9a9-4b79-b94a-a7160d964385 61 fields · synced Jun 18, 2026