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Disposable Dilation Balloon Catheters
EUDAMEDClass IIa (EU MDR)
Ref ENDO-DB2-07-1855-250Model ENDO-DB
Identity
- Device Name
- Disposable Dilation Balloon Catheters EUDAMED
- Model / Reference
- ENDO-DB EUDAMEDENDO-DB2-07-1855-250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975597851585 EUDAMED
- Basic UDI-DI
- 697559785PE09UL EUDAMED
- EMDN Code
- G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Disposable Dilation Balloon Catheters by Jiangsu Power-endo Medical Technology Co., Ltd — Class IIa — 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 | 697559785PE09UL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Power-endo Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000030213
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED b4f88489-eaec-425e-a000-2b46e7fa7ca5 61 fields · synced Jun 18, 2026