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Disposable Electrode Surgical Instrument
EUDAMEDClass IIb (EU MDR)
Ref F00010Ref F00009Ref F00008Ref F00016Ref F00031Ref F00015Ref F00007Ref F00018
Identity
- Device Name
- Disposable Electrode Surgical Instrument EUDAMED
- Model / Reference
- F00010 EUDAMEDF00009 EUDAMEDF00008 EUDAMEDF00016 EUDAMEDF00031 EUDAMEDF00015 EUDAMEDF00007 EUDAMEDF00018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937893904433 EUDAMED06937893900565 EUDAMED06937893903382 EUDAMED06937893903238 EUDAMED06937893900657 EUDAMED06937893900633 EUDAMED06937893900541 EUDAMED06937893904556 EUDAMED
- Basic UDI-DI
- 69378939F005S EUDAMED
- EMDN Code
- K02010199 MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Disposable Electrode Surgical Instrument by Tonglu Qianyan Medtech Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69378939F005S | Class IIb | Active |
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Manufacturer
- Manufacturer
- Tonglu Qianyan Medtech Co., Ltd
- EUDAMED SRN
- CN-MF-000017342
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (8)
- EUDAMED 30fcec77-a81a-4db5-a048-f13ce4df8c31 61 fields · synced Aug 3, 2026
- EUDAMED a0e52698-7293-4e5b-b3ed-6e64be81bf3d 61 fields · synced May 16, 2026
- EUDAMED 24a94312-982e-45e4-8a08-3e41c7139094 61 fields · synced May 16, 2026
- EUDAMED 36ae9905-f843-4280-8476-b4e74f112048 61 fields · synced May 18, 2026
- EUDAMED 810423c8-1f71-4f77-a337-db2a39a42292 61 fields · synced May 19, 2026
- EUDAMED f060c9de-3c80-45df-9697-b5afddd44411 61 fields · synced May 19, 2026
- EUDAMED 1f60a8cc-4145-4c90-bf63-47feccd2ca7c 61 fields · synced May 19, 2026
- EUDAMED 5f682d26-8fe4-4c8e-98ba-956b78906084 61 fields · synced May 19, 2026