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Wireguided Balloon Dilation Catheter
EUDAMEDClass IIa (EU MDR)
Ref CIT-WBD-D-55-180
by Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
Identity
- Trade Name
- Wireguided Balloon Dilation Catheter EUDAMED
- Device Name
- Wireguided Balloon Dilation Catheter EUDAMED
- Model / Reference
- CIT-WBD-D-55-180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970057554136 EUDAMED
- Basic UDI-DI
- B-06970057554136 EUDAMED
- EMDN Code
- G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Wireguided Balloon Dilation Catheter by Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. — Class IIa — MDD — listed in EUDAMED
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-06970057554136 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010512
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 23113b5f-ad83-41b4-b00a-87e025bc9196 61 fields · synced Oct 6, 2026