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Extraction Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref AF-D5520GE08Model Extraction Balloon Catheter
Identity
- Trade Name
- Extraction Balloon Catheter EUDAMED
- Device Name
- Extraction Balloon Catheter EUDAMED
- Model / Reference
- Extraction Balloon Catheter EUDAMEDAF-D5520GE08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942127890147 EUDAMED
- Basic UDI-DI
- 697067138EB045BJ 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
Yes
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
Extraction Balloon Catheter by Alton (Shanghai) Medical Instruments 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 | 697067138EB045BJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alton (Shanghai) Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000012832
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED cd663229-9805-4997-9a55-bd860311d9e9 61 fields · synced Oct 6, 2026