← Back to catalogue
Balloon Ureteral Dilator
EUDAMEDClass IIa (EU MDR)
Ref AF-DUB0404Model Balloon Ureteral DilatorRef AF-DUB0510FRef AF-DUB0410BRef AF-DUB0708B
Identity
- Trade Name
- Balloon Ureteral Dilator EUDAMED
- Device Name
- Balloon Ureteral Dilator EUDAMED
- Model / Reference
- Balloon Ureteral Dilator EUDAMEDAF-DUB0404 EUDAMEDAF-DUB0510F EUDAMEDAF-DUB0410B EUDAMEDAF-DUB0708B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942127889073 EUDAMED06942127889752 EUDAMED06942127889462 EUDAMED06942127889608 EUDAMED
- Basic UDI-DI
- 697067138BU054EP EUDAMED
- EMDN Code
- U030201 URETHRAL DILATORS, WITH BALLOON 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
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
Balloon Ureteral Dilator 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 | 697067138BU054EP | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 (4)
- EUDAMED eed74eaa-246b-4d83-8c1b-f932dd9307a3 61 fields · synced Oct 6, 2026
- EUDAMED 4474fce7-2919-44db-874e-5fd3ec79c493 61 fields · synced Jul 8, 2026
- EUDAMED 2b1addd1-daf9-48fc-bb57-8e6ac62ddff7 61 fields · synced Aug 1, 2026
- EUDAMED 787a62b7-786d-4391-b4c1-4b55bfd20dcb 61 fields · synced Aug 1, 2026