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Infusion Sets
EUDAMEDClass I (EU MDR)
Ref IV010000Model IV010000、 IV010003、 IV012000Ref IV010003Ref IV012000
Identity
- Trade Name
- Infusion Sets EUDAMED
- Device Name
- Infusion Sets EUDAMED
- Model / Reference
- IV010000、 IV010003、 IV012000 EUDAMEDIV010000 EUDAMEDIV010003 EUDAMEDIV012000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013966144 EUDAMED06972013966151 EUDAMED06972013966168 EUDAMED09341601000008 EUDAMED09341601004600 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSIS0026X EUDAMED
- Direct Marketing DI
- 06972013966144 EUDAMED06972013966151 EUDAMED06972013966168 EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion Sets by Multigate 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 | 697201396MU01SNNNSIS0026X | Class I | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (8)
- EUDAMED 0344abdc-827e-40f8-a35c-cc3ffb4b7606 61 fields · synced Sep 18, 2026
- EUDAMED ae1683dd-7105-4dee-a1e1-621938f77641 61 fields · synced May 18, 2026
- EUDAMED 673be4b9-0b61-4c37-9c1c-6b5effaaf05a 61 fields · synced May 19, 2026
- EUDAMED f46b7585-e1e6-457b-943b-a5ed1cd8bcda 61 fields · synced Jun 20, 2026
- EUDAMED 8085b882-1e0f-4309-b3cc-3504546e69c2 61 fields · synced Jul 10, 2026
- EUDAMED e02bbf02-44b0-4c03-9b0e-cac2fbd506f4 61 fields · synced Jul 22, 2026
- EUDAMED 9343b108-a4fe-4a88-a6d9-0a2fc991e42f 61 fields · synced Sep 18, 2026
- EUDAMED 881b0def-a17d-477a-8114-ece2427b424a 61 fields · synced Sep 18, 2026