Bougie Dilator Set
by Changzhou Jiuhong Medical Instrument Co., Ltd. China EUDAMED
Ref JHK-19 EMDN G010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-06942000240724 | Date18 Apr 2026 | StatusActive |
| European Union | CE/MDD | NumberB-06942000240724 | Date18 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- Bougie Dilator SetBougie Dilators
- Model / Reference
- JHK-19
- Primary DI / UDI-DI
- 06942000240724, 06942000201091
- Basic UDI-DI
- B-06942000240724, 69420002050N6
- EMDN Code
- G010102 Cardias dilatation tubes
- Device Class
- Class IClass IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000016791
- Authorised representative
- Prolinx GmbH DE-AR-000005129
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (3)
- EUDAMED beb5d09b-e131-4e7d-b7d9-f3b3d93e1d8e
- EUDAMED 06942000240724|69420002050N6
- EUDAMED 06942000201091|69420002050N6