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Bipolar Forceps
EUDAMEDClass IIb (EU MDR)
Ref J17Model SDTFQM-40Ref J21Ref J13Ref J14Ref J20Ref J5Ref J7U
Identity
- Trade Name
- Bipolar Forceps EUDAMED
- Device Name
- Bipolar Wand EUDAMED
- Model / Reference
- SDTFQM-40 EUDAMEDJ17 EUDAMEDJ21 EUDAMEDJ13 EUDAMEDJ14 EUDAMEDJ20 EUDAMEDJ5 EUDAMEDJ7U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810026182594 EUDAMED00810026182631 EUDAMED00810026182570 EUDAMED00810026182587 EUDAMED00810026182624 EUDAMED00810026182532 EUDAMED00810026182563 EUDAMED
- Basic UDI-DI
- 0081002618SDTFQM-40TQ EUDAMED
- EMDN Code
- L180401 OPEN ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Bipolar Forceps by Soniquence, LLC — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0081002618SDTFQM-40TQ | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0081002618SDTFQM-40TQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Soniquence, LLC
- EUDAMED SRN
- US-MF-000029810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (7)
- EUDAMED 82468533-0235-4d25-9bb6-8fa334e5c208 61 fields · synced Jul 28, 2026
- EUDAMED 787efc8b-cde1-46ef-b555-df025f55f9b6 61 fields · synced May 17, 2026
- EUDAMED 90092893-c7c4-4b7a-af5c-248909750efa 61 fields · synced May 17, 2026
- EUDAMED 5dd3d338-f0d3-4560-b45c-c753aa19fc78 61 fields · synced May 17, 2026
- EUDAMED b5320d39-1ccf-4d0c-b4ec-db35c24e28bf 61 fields · synced May 18, 2026
- EUDAMED 6dfcb98b-96ab-41f4-a889-3963e4899a5a 61 fields · synced May 19, 2026
- EUDAMED 48f7c7f5-4e5b-4995-9414-af3f7e944d7f 61 fields · synced May 19, 2026