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Stone Extraction Balloon
EUDAMEDClass IIa (EU MDR)
Ref CIT-BAL-23-9/12/15-B
by Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
Identity
- Trade Name
- Stone Extraction Balloon EUDAMED
- Device Name
- Stone Extraction Balloon EUDAMED
- Model / Reference
- CIT-BAL-23-9/12/15-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970057553580 EUDAMED
- Basic UDI-DI
- B-06970057553580 EUDAMED
- EMDN Code
- G03050101 DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Stone Extraction Balloon by Changzhou Intl. Trade & Enterprises Cooperative 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-06970057553580 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010512
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 2eb6eef4-5487-486f-bafa-14f9fccad210 61 fields · synced Jun 18, 2026