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Infusion sets
EUDAMEDClass IIa (EU MDR)
Ref PM 10001Model PM10001, PM10001W, PM10002, PM10003SAFE, PM10004AMBER, PM10005, PM10006, PM10007, PM10008, PM10009, PM10010, PM10011
Identity
- Device Name
- Infusion sets EUDAMED
- Model / Reference
- PM10001, PM10001W, PM10002, PM10003SAFE, PM10004AMBER, PM10005, PM10006, PM10007, PM10008, PM10009, PM10010, PM10011 EUDAMEDPM 10001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-PM10001MX EUDAMED
- Basic UDI-DI
- B-PM10001MX EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion sets by Ningbo Pinmed Instruments 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-PM10001MX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Pinmed Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000008488
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED e71e6ae2-3e72-4795-a7fb-a6e1d87bd39f 61 fields · synced Jun 19, 2026