← Back to catalogue

Sterile Urinary Catheter for single use

EUDAMED

Class IIa (EU MDR)

Ref NAModel Silicone-2-way-2.0mm(6Fr/CH)-(Balloon capacity: 1.5cc/ml)、Silicone-2-way-2.7mm(8Fr/CH)-(Balloon capacity: 1-2cc/ml) 、Silicone-2-way-3.3mm(10Fr/CH)-(Balloon capacity: 3-5ml)、Silicone-2-way-4.0mm(12Fr/CH)-(Balloon capacity: 5-10ml)

by Jiangsu Suyun Medical Materials Co., Ltd.

Identity

Device Name
Sterile Urinary Catheter for single use EUDAMED
Model / Reference
Silicone-2-way-2.0mm(6Fr/CH)-(Balloon capacity: 1.5cc/ml)、Silicone-2-way-2.7mm(8Fr/CH)-(Balloon capacity: 1-2cc/ml) 、Silicone-2-way-3.3mm(10Fr/CH)-(Balloon capacity: 3-5ml)、Silicone-2-way-4.0mm(12Fr/CH)-(Balloon capacity: 5-10ml) EUDAMED
NA EUDAMED

Identifiers

Primary DI / UDI-DI
16933298294619 EUDAMED
Basic UDI-DI
69332982010V5 EUDAMED
EMDN Code
U010202 URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Bulgaria EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

Yes

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

Sterile Urinary Catheter for single use by Jiangsu Suyun Medical Materials Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Jiangsu Suyun Medical Materials Co., Ltd.
EUDAMED SRN
CN-MF-000021132
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED fa2ed75e-3ed0-44e5-8eeb-bcb557027c89 61 fields · synced Jun 19, 2026