← Back to catalogue
Gastrointestinal and Biliary Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref CIT-BD-06-40-200
by Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
Identity
- Trade Name
- Gastrointestinal and Biliary Balloon Catheter EUDAMED
- Device Name
- Gastrointestinal and Biliary Balloon Catheter EUDAMED
- Model / Reference
- CIT-BD-06-40-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970057553016 EUDAMED
- Basic UDI-DI
- B-06970057553016 EUDAMED
- EMDN Code
- G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Gastrointestinal and Biliary Balloon 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-06970057553016 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000010512
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED dbb2f668-2d7f-4beb-a055-bb8a0873f49f 61 fields · synced Jul 9, 2026