Identity
- Trade Name
- Bipolar Forceps EUDAMED
- Device Name
- Bipolar Wand EUDAMED
- Model / Reference
- SDTFQM-40 EUDAMEDJ7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810026182549 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
Bipolar Forceps by Soniquence, LLC — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (1)
- EUDAMED e362dd61-7976-4bb2-ac1c-584d7e5efc43 61 fields · synced Jun 20, 2026