Identity
- Trade Name
- Bougie Dilator Set EUDAMED
- Device Name
- Bougie Dilator Set EUDAMED
- Model / Reference
- JHK-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942000240335 EUDAMED
- Basic UDI-DI
- B-06942000240335 EUDAMED
- EMDN Code
- G03010201 DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Set 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-06942000240335 | 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 000401f5-06ac-4c7c-9bc2-9143cddd8a5a 61 fields · synced Oct 7, 2026