Identity
- Trade Name
- Disposable Infusion Set EUDAMED
- Device Name
- Disposable Infusion Set EUDAMED
- Model / Reference
- A311M021F EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972991860687 EUDAMED
- Basic UDI-DI
- B-06972991860687 EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Infusion Set by Medcaptain Life Science Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972991860687 | 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 (1)
- EUDAMED a66290db-4d0e-4001-a0f4-7486803f46f4 61 fields · synced Jun 18, 2026