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Extension Set
EUDAMEDClass I (EU MDR)
Ref IV051010Model IV050140、IV051004、IV051010、IV052000
Identity
- Trade Name
- Extension Set EUDAMED
- Device Name
- Extension Set EUDAMED
- Model / Reference
- IV050140、IV051004、IV051010、IV052000 EUDAMEDIV051010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013966120 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSES0015H EUDAMED
- Direct Marketing DI
- 06972013966120 EUDAMED
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES 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
Extension Set 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 | 697201396MU01SNNNSES0015H | 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 (2)
- EUDAMED a893c852-33ba-487e-af3e-3b1c16951353 61 fields · synced Jun 18, 2026
- EUDAMED bee28261-e7ed-47c4-a6cf-44e323e8495a 61 fields · synced Jun 18, 2026