Identity
- Trade Name
- Bougie Dilator Sets EUDAMED
- Device Name
- Bougie Dilator Sets EUDAMED
- Model / Reference
- JHK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942000203002 EUDAMED
- Basic UDI-DI
- B-06942000203002 EUDAMED
- EMDN Code
- G010102 CARDIAS DILATATION TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bougie Dilator Sets by Changzhou Jiuhong Medical Instrument Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06942000203002 | 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 (1)
- EUDAMED abc63a6f-aceb-4f4c-943f-a42b67275bb0 61 fields · synced Oct 7, 2026