Bipolar Wand

by Soniquence, LLC 32 variants

Ref SCBS-SModel SDTFQM-40

Active European Union

CE MDR

Valid until

12 Feb 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number0081002618SDTFQM-40TQ Basic UDI-DI 00810026182471UDI-DI	Date11 Aug 2025Registered	StatusActive
European Union	CE/MDR	Number28620156587-01	Date16 Jun 2025Issued	StatusActive expires 12 Feb 2028

Certificates

1 certificate · EUDAMED

28620156587-01 Active Supplemented

Quality management system EU MDR

Certifier

Intertek Medical Notified Body AB 2862

Issued
16 Jun 2025

Expires
12 Feb 2028

Reason
Change approved

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference: SDTFQM-40, SCBS-S

Primary DI / UDI-DI: 00810026182471
Basic UDI-DI: 0081002618SDTFQM-40TQ
EMDN Code: K0201010301 Open electrosurgery electrodes, single-use

Device Class: Class IIb
EU market of registration: France

Manufacturer details

EUDAMED SRN: US-MF-000029810
Authorised representative: Emergo Europe B.V. NL-AR-000000116

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Properties

Sterile

Other properties (12)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No