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Foley Catheter for single use latex Two-way with ballone 2.0mm(6Fr)

EUDAMED

Class IIa (EU MDR)

Ref FR06DModel Model：Two-way with ballonet, Three-way with ballonet； Specifications：2.0mm(6Fr), 2.7mm(8Fr), 3.3mm(10Fr), 4.0mm(12Fr), 4.7mm(14Fr), 5.3mm(16Fr),6.0mm(18Fr),6.7mm(20Fr),7.3mm(22Fr),8.0mm(24Fr), 8.7mm(26Fr), 9.3mm(28Fr), 10.0mm(30Fr).

by Jiangxi Hongda Medical Equipment Group Ltd.

Identity

Trade Name
Foley Catheter for single use latex Two-way with ballone 2.0mm(6Fr) EUDAMED
Device Name
Foley Catheter for single use EUDAMED
Model / Reference
Model：Two-way with ballonet, Three-way with ballonet； Specifications：2.0mm(6Fr), 2.7mm(8Fr), 3.3mm(10Fr), 4.0mm(12Fr), 4.7mm(14Fr), 5.3mm(16Fr),6.0mm(18Fr),6.7mm(20Fr),7.3mm(22Fr),8.0mm(24Fr), 8.7mm(26Fr), 9.3mm(28Fr), 10.0mm(30Fr). EUDAMED
FR06D EUDAMED

Identifiers

Primary DI / UDI-DI
06920756758335 EUDAMED
Basic UDI-DI
69207567DNG0001GL EUDAMED
EMDN Code
U020202 URETERAL CATHETERS WITH FLUTE TIP WITH BALLOON EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Hungary 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

Foley Catheter for single use latex Two-way with ballone 2.0mm(6Fr) by Jiangxi Hongda Medical Equipment Group Ltd. — Class IIa — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Jiangxi Hongda Medical Equipment Group Ltd.
EUDAMED SRN
CN-MF-000006019
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 9e0662c6-d160-4c5e-9f5e-bfe3dca392ff 61 fields · synced Oct 5, 2026