Identity
- Trade Name
- Bougie Dilator Set EUDAMEDBougie Dilators EUDAMED
- Device Name
- Bougie Dilator Set EUDAMEDBougie Dilators EUDAMED
- Model / Reference
- JHK-08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942000240694 EUDAMED06942000201008 EUDAMED
- Basic UDI-DI
- B-06942000240694 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 — CE/MDR — 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-06942000240694 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changzhou Jiuhong Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000016791
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 5161a4d5-2fca-4c26-8c98-11a2425edd40 61 fields · synced Oct 7, 2026
- EUDAMED 140d0845-bf0d-416b-a182-18602e807adc 61 fields · synced Oct 7, 2026