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Disposable Endoscopy Dilation Balloon

EUDAMED

Class IIa (EU MDR)

Ref AF-D0709BC0660FModel Disposable Endoscopy Dilation BalloonRef AF-D0720BC1460FRef AF-D0718BC1860F

by Alton (Shanghai) Medical Instruments Co., Ltd.

Identity

Trade Name
Disposable Endoscopy Dilation Balloon EUDAMED
Device Name
Disposable Endoscopy Dilation Balloon EUDAMED
Model / Reference
Disposable Endoscopy Dilation Balloon EUDAMED
AF-D0709BC0660F EUDAMED
AF-D0720BC1460F EUDAMED
AF-D0718BC1860F EUDAMED

Identifiers

Primary DI / UDI-DI
06942127888625 EUDAMED
06942127888854 EUDAMED
06942127888779 EUDAMED
Basic UDI-DI
697067138BC044AN EUDAMED
EMDN Code
G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany 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 Endoscopy Dilation Balloon by Alton (Shanghai) Medical Instruments 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
Alton (Shanghai) Medical Instruments Co., Ltd.
EUDAMED SRN
CN-MF-000012832
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (3)

  • EUDAMED 4f6c161c-bfd0-4268-ab9c-4103434ef265 61 fields · synced Oct 6, 2026
  • EUDAMED fbb3c0ca-1c1a-4808-adc0-9753332373b6 61 fields · synced Jul 8, 2026
  • EUDAMED 641abb95-3b5a-4b0c-8708-e1e4f95e11e9 61 fields · synced Aug 1, 2026