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3-stage Dilation Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref CIT-TBD-E-55-180
by Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
Identity
- Trade Name
- 3-stage Dilation Balloon Catheter EUDAMED
- Device Name
- 3-stage Dilation Balloon Catheter EUDAMED
- Model / Reference
- CIT-TBD-E-55-180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970057554174 EUDAMED
- Basic UDI-DI
- B-06970057554174 EUDAMED
- EMDN Code
- G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER 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
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
3-stage Dilation 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-06970057554174 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010512
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 07de6363-e98f-4364-aac4-5961e5e73c12 61 fields · synced Jun 19, 2026