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Disposable Stone Extraction Balloon
EUDAMEDClass IIa (EU MDR)
Ref JHY-BAL-23-10/13/16-BRef JHY-BAL-23-10/13/16-C
Identity
- Trade Name
- Disposable Stone Extraction Balloon EUDAMED
- Device Name
- Disposable Stone Extraction Balloon EUDAMED
- Model / Reference
- JHY-BAL-23-10/13/16-B EUDAMEDJHY-BAL-23-10/13/16-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942000229033 EUDAMED06942000229101 EUDAMED
- Basic UDI-DI
- B-06942000229033 EUDAMEDB-06942000229101 EUDAMED
- EMDN Code
- G03050101 DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Disposable Stone Extraction Balloon by Changzhou Jiuhong Medical Instrument Co., Ltd. — Class IIa — 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-06942000229033 | Class IIa | 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 (2)
- EUDAMED c73b4bd0-14c5-4303-95bd-8f88cf293f89 61 fields · synced Oct 6, 2026
- EUDAMED 4cbb6233-9087-4895-b4e1-7291e45dc34f 61 fields · synced May 19, 2026