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Single Use Balloon Dilatation Catheters
EUDAMEDClass I (EU MDR)
Ref MD-A-DB-2312-1230
Identity
- Trade Name
- Single Use Balloon Dilatation Catheters EUDAMED
- Device Name
- Single Use Balloon Dilatation Catheters EUDAMED
- Model / Reference
- MD-A-DB-2312-1230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942804701162 EUDAMED
- Basic UDI-DI
- 69365343DBArespiratoryDJ EUDAMED
- EMDN Code
- R050201 BRONCHIAL DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Single Use Balloon Dilatation Catheters by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69365343DBArespiratoryDJ | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000012417
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 951dcda8-7478-438a-8e49-d94c6a24532e 61 fields · synced Jun 19, 2026