OP-Set

by Sengewald Klinikprodukte GmbH 6 variants

Ref 66729614-03Model 66817964-06

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number4034393CPTGYN2A2W Basic UDI-DI 04034393805009UDI-DI	Date8 May 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Mamma Set
Model / Reference: 66817964-06, 66729614-03

Primary DI / UDI-DI: 04034393805009
Basic UDI-DI: 4034393CPTGYN2A2W
EMDN Code: Z129099 Various instruments for functional exploration and therapeutic interventions - other

Device Class: Class IIa
Medical Purpose: Sterile, disposable procedure pack, combination of devices for disease treatment or for a physiological state related to gynecology and obstetrics.

Manufacturer details

EUDAMED SRN: DE-PR-000020748

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Properties

Sterile