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Extension Set
EUDAMEDClass IIa (EU MDR)
Ref IV050000Model 25cm、75cm、150cm、200cmModel IV050000、IV050001、IV050002、IV050003
Identity
- Trade Name
- Extension Set EUDAMED
- Device Name
- Extension Set EUDAMED
- Model / Reference
- 25cm、75cm、150cm、200cm EUDAMEDIV050000 EUDAMEDIV050000、IV050001、IV050002、IV050003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013963884 EUDAMED
- Basic UDI-DI
- 697201396MU2ASNNNSES001NC EUDAMED
- Direct Marketing DI
- 06972013963884 EUDAMED
- EMDN Code
- A03020199 EXTENSIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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 IIa — 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 | 697201396MU2ASNNNSES001NC | Class IIa | 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 df9bf6cf-70b0-48c3-813c-6d66130cb0dc 61 fields · synced Jun 18, 2026
- EUDAMED 8b1c9baf-d3f6-4193-a7e0-9276f2f11e15 61 fields · synced Jun 18, 2026