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Infusion Sets
EUDAMEDClass I (EU MDR)
Ref IV010003Model IV010000、 IV010003、 IV012000
Identity
- Trade Name
- Infusion Sets EUDAMED
- Device Name
- Infusion Sets EUDAMED
- Model / Reference
- IV010000、 IV010003、 IV012000 EUDAMEDIV010003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09341601005140 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSIS0026X 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 (1)
- EUDAMED 9fea9321-41d9-4f47-8120-ddcbcf5d297b 61 fields · synced Jun 18, 2026