Identity
- Trade Name
- Extension Set EUDAMED
- Device Name
- Extension Set EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974909516150 EUDAMED
- Basic UDI-DI
- 697490951CM61A01KP EUDAMED
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Extension Set by Medcaptain Life Science Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230528 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697490951CM61A01KP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medcaptain Life Science Co., Ltd.
- EUDAMED SRN
- CN-MF-000006656
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED ed906405-1f88-4b6c-abc5-718a320c657a 85 fields · synced Jun 18, 2026
- FDA 510(k) K230528 1 fields · synced May 18, 2026