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Medical Balloon Catheter Syringe Pump
EUDAMEDClass I (EU MDR)
Ref FG4203Model FG4201, FG4203
Identity
- Device Name
- Medical Balloon Catheter Syringe Pump EUDAMED
- Model / Reference
- FG4201, FG4203 EUDAMEDFG4203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938695501066 EUDAMED
- Basic UDI-DI
- 69386955SPLS7L EUDAMED
- Direct Marketing DI
- 06938695501066 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class I 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
Medical Balloon Catheter Syringe Pump by Shanghai Kinetic Medical Co., Ltd. — Class I — 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 | 69386955SPLS7L | Class I | 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 eee6ebca-bf4b-4c38-be18-fc9b08637b49 61 fields · synced May 29, 2026