Bougie Dilator Set

EUDAMED

Class I (EU MDR)

Ref JHK-12

by Changzhou Jiuhong Medical Instrument Co., Ltd.

Identity

Trade Name: Bougie Dilator Set EUDAMED
Bougie Dilators EUDAMED
Device Name: Bougie Dilator Set EUDAMED
Bougie Dilators EUDAMED
Model / Reference: JHK-12 EUDAMED

Identifiers

Primary DI / UDI-DI: 06942000240519 EUDAMED
Basic UDI-DI: B-06942000240519 EUDAMED
69420002050N6 EUDAMED
EMDN Code: G03010201 DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS EUDAMED
G010102 CARDIAS DILATATION TUBES EUDAMED

Classification

Device Class: Class I EUDAMED
Class IIa EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Bougie Dilator Set by Changzhou Jiuhong Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-06942000240519	Class I	Active

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Manufacturer

Manufacturer: Changzhou Jiuhong Medical Instrument Co., Ltd.
EUDAMED SRN: CN-MF-000016791
Authorised Representative: Prolinx GmbH DE-AR-000005129

Sources (2)

EUDAMED e4104400-5ada-49bb-808d-1a8451fc2d52 61 fields · synced Oct 8, 2026
EUDAMED c7159eed-9742-49ac-849e-8a1bc394d132 61 fields · synced Oct 8, 2026