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Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref FB2015Model FB2010, FB2015, FB2020, FB2025, FB2030, FB2110, FB2115, FB2120
Identity
- Device Name
- Balloon Catheter EUDAMED
- Model / Reference
- FB2010, FB2015, FB2020, FB2025, FB2030, FB2110, FB2115, FB2120 EUDAMEDFB2015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938695520180 EUDAMED
- Basic UDI-DI
- 69386955BXKZ EUDAMED
- Direct Marketing DI
- 06938695520180 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS 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 Catheter by Shanghai Kinetic Medical 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 | 69386955BXKZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Kinetic Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017688
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 9e496bfc-5977-4737-9aa4-5445b716b9ce 61 fields · synced May 22, 2026