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Disposable Dilation Balloon Catheters

EUDAMED

Class IIa (EU MDR)

Ref ENDO-DB1-10-4080-90Model ENDO-DB

by Jiangsu Power-endo Medical Technology Co., Ltd

Identity

Device Name
Disposable Dilation Balloon Catheters EUDAMED
Model / Reference
ENDO-DB EUDAMED
ENDO-DB1-10-4080-90 EUDAMED

Identifiers

Primary DI / UDI-DI
06975597851516 EUDAMED
Basic UDI-DI
697559785PE09UL EUDAMED
EMDN Code
G0301010201 ACHALASIA BALLOON CATHETERS, LOW PRESSURE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

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

Disposable Dilation Balloon Catheters by Jiangsu Power-endo Medical Technology 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

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Manufacturer

EUDAMED SRN
CN-MF-000030213
Authorised Representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (1)

  • EUDAMED c724e362-7ed9-4418-bc93-0f4c35dc0b12 61 fields · synced Jun 18, 2026