Atropos Pro

by BrosMed Medical Co., Ltd 216 variants

Ref A35-070200-070

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

Overview

Atropos Pro/Parafleet SC035 PTA Balloon Dilatation Catheter is a medical device used for balloon dilatation in the treatment of atrophic vaginitis.

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number695848140065MK Basic UDI-DI 06958481480306UDI-DI	Date19 Aug 2024Registered	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Withdrawn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: Atropos Pro / Parafleet SC 035 PTA Balloon Dilatation Catheter
Model / Reference: A35-070200-070

Primary DI / UDI-DI: 06958481480306
Basic UDI-DI: 695848140065MK
EMDN Code: C010402020101 PTA balloon dilatation catheters

Device Class: Class IIa
EU market of registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000007501
Authorised representative: Brosmed Medical B.V. NL-AR-000002616

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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