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Bougie Dilator Set
EUDAMEDClass I (EU MDR)
Ref JHK-16Ref JHK-08Ref JHK-05Ref JHK-12Ref JHK-13Ref JHK-15Ref JHK-19Ref JHK-06
Identity
- Trade Name
- Bougie Dilator Set EUDAMEDBougie Dilators EUDAMED
- Device Name
- Bougie Dilator Set EUDAMEDBougie Dilators EUDAMED
- Model / Reference
- JHK-16 EUDAMEDJHK-08 EUDAMEDJHK-05 EUDAMEDJHK-12 EUDAMEDJHK-13 EUDAMEDJHK-15 EUDAMEDJHK-19 EUDAMEDJHK-06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942000240571 EUDAMED06942000240694 EUDAMED06942000240304 EUDAMED06942000240519 EUDAMED06942000240427 EUDAMED06942000240458 EUDAMED06942000240724 EUDAMED06942000240663 EUDAMED06942000201008 EUDAMED
- Basic UDI-DI
- B-06942000240571 EUDAMEDB-06942000240694 EUDAMEDB-06942000240304 EUDAMEDB-06942000240519 EUDAMEDB-06942000240427 EUDAMEDB-06942000240458 EUDAMEDB-06942000240724 EUDAMEDB-06942000240663 EUDAMED69420002050N6 EUDAMED
- EMDN Code
- G03010201 DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS EUDAMEDG010102 CARDIAS DILATATION TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass 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
Bougie Dilator Set by Changzhou Jiuhong Medical Instrument Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06942000240571 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06942000240571 | 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 (9)
- EUDAMED 9b8ca22f-31a9-4d0b-8c07-f7e8b2f92798 61 fields · synced Oct 7, 2026
- EUDAMED 5161a4d5-2fca-4c26-8c98-11a2425edd40 61 fields · synced May 17, 2026
- EUDAMED 02576855-1787-49d4-bf1b-b5e350466b3b 61 fields · synced May 17, 2026
- EUDAMED e4104400-5ada-49bb-808d-1a8451fc2d52 61 fields · synced May 17, 2026
- EUDAMED 710c0dd5-38a4-49e9-aa15-8f4435048610 61 fields · synced May 18, 2026
- EUDAMED d6bbec98-3c5e-44d0-a787-c23b377b9c7a 61 fields · synced May 18, 2026
- EUDAMED beb5d09b-e131-4e7d-b7d9-f3b3d93e1d8e 61 fields · synced May 19, 2026
- EUDAMED 9b9ad874-872c-4510-bfb6-8c8fd194edce 61 fields · synced May 19, 2026
- EUDAMED 140d0845-bf0d-416b-a182-18602e807adc 61 fields · synced Oct 7, 2026