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Sterile Infusion Sets for Single Use
EUDAMEDClass IIa (EU MDR)
Ref IVDM018-LLModel 21G-01
Identity
- Device Name
- Sterile Infusion Sets for Single Use EUDAMED
- Model / Reference
- 21G-01 EUDAMEDIVDM018-LL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971077613377 EUDAMED
- Basic UDI-DI
- B-06971077613377 EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Sterile Infusion Sets for Single Use by Zibo Eastmed Healthcare Products 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-06971077613377 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zibo Eastmed Healthcare Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000032259
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED 4a226ab5-4153-4363-9806-d5feec7a6a24 61 fields · synced Jun 19, 2026