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Disposable Dilation Balloon Catheters

EUDAMED

Class IIa (EU MDR)

Ref ENDO-DB1-07-1680-250Model ENDO-DBRef ENDO-DB2-07-1580-250Ref ENDO-DB1-07-0640-250Ref ENDO-DB2-07-0630-250Ref ENDO-DB1-07-2060-250Ref ENDO-DB1-10-2580-90Ref ENDO-DB2-07-1280-250Ref ENDO-DB1-07-1860-250Ref ENDO-DB1-07-1460-250Ref ENDO-DB1-10-3580-90Ref ENDO-DB1-07-2080-250Ref ENDO-DB2-07-1255-250Ref ENDO-DB2-07-1055-250

by Jiangsu Power-endo Medical Technology Co., Ltd

Identity

Device Name
Disposable Dilation Balloon Catheters EUDAMED
Model / Reference
ENDO-DB EUDAMED
ENDO-DB1-07-1680-250 EUDAMED
ENDO-DB2-07-1580-250 EUDAMED
ENDO-DB1-07-0640-250 EUDAMED
ENDO-DB2-07-0630-250 EUDAMED
ENDO-DB1-07-2060-250 EUDAMED
ENDO-DB1-10-2580-90 EUDAMED
ENDO-DB2-07-1280-250 EUDAMED
ENDO-DB1-07-1860-250 EUDAMED
ENDO-DB1-07-1460-250 EUDAMED
ENDO-DB1-10-3580-90 EUDAMED
ENDO-DB1-07-2080-250 EUDAMED
ENDO-DB2-07-1255-250 EUDAMED
ENDO-DB2-07-1055-250 EUDAMED

Identifiers

Primary DI / UDI-DI
06975597851431 EUDAMED
06975597851608 EUDAMED
06975597851370 EUDAMED
06975597851530 EUDAMED
06975597851462 EUDAMED
06975597851486 EUDAMED
06975597851592 EUDAMED
06975597851448 EUDAMED
06975597851417 EUDAMED
06975597851509 EUDAMED
06975597851479 EUDAMED
06975597851561 EUDAMED
06975597851554 EUDAMED
Basic UDI-DI
697559785PE09UL EUDAMED
EMDN Code
G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER EUDAMED
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

Manufacturer
Jiangsu Power-endo Medical Technology Co., Ltd
EUDAMED SRN
CN-MF-000030213
Authorised Representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (13)

  • EUDAMED a417f3b3-bbe0-414f-a7eb-fd6f6e48e094 61 fields · synced Oct 6, 2026
  • EUDAMED 600f66bc-dc4d-4908-a4c6-eeb4149d013b 61 fields · synced May 16, 2026
  • EUDAMED d7f25bb0-792c-4eb7-be7d-46884881a1c7 61 fields · synced May 16, 2026
  • EUDAMED 94cff795-5d30-43de-bd3a-f59dfcb130d2 61 fields · synced May 17, 2026
  • EUDAMED e4d1a8d8-b3a6-4fb1-bb81-2bcd5ff07b11 61 fields · synced May 17, 2026
  • EUDAMED 3eb73198-2430-4d50-9f1d-64faa243bd56 61 fields · synced May 17, 2026
  • EUDAMED 21011d8f-d304-48b9-a8ca-c9b5d290220c 61 fields · synced May 17, 2026
  • EUDAMED cc02a16c-e0ab-4e43-ad65-8da7a89a6ca4 61 fields · synced May 17, 2026
  • EUDAMED 2ea45ed5-176d-4c4f-8759-7647853e8a7a 61 fields · synced May 18, 2026
  • EUDAMED cc9915ac-7003-4c81-aaca-699d1628c57e 61 fields · synced May 18, 2026
  • EUDAMED 9d11f0bc-9223-4100-887b-82f604e0a529 61 fields · synced May 18, 2026
  • EUDAMED 7dc88d03-7954-4dc9-8648-43d86efba544 61 fields · synced May 19, 2026
  • EUDAMED 9aeeb21c-6afc-4c04-821e-ab703c78f8cf 61 fields · synced May 19, 2026