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Burettes Infusion Sets
EUDAMEDClass IIa (EU MDR)
Ref IV040002Ref IV040001Ref IV040002
Identity
- Trade Name
- Burettes Infusion Sets EUDAMED
- Device Name
- Burettes Infusion Sets EUDAMED
- Model / Reference
- IV040002 EUDAMEDIV040001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013966090 EUDAMED06972013963983 EUDAMED09341601000176 EUDAMED09341601000183 EUDAMED
- Basic UDI-DI
- 697201396MU2ASNNMSBU002MA EUDAMED697201396MU01SNNMSBU0014D EUDAMED
- Direct Marketing DI
- 06972013966090 EUDAMED06972013963983 EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Burettes Infusion Sets 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 | 697201396MU2ASNNMSBU002MA | 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 (6)
- EUDAMED 09cd04bd-cd25-41c5-9b3a-adf6e6d96b00 61 fields · synced Aug 2, 2026
- EUDAMED e8bb7cfb-09af-49e7-b330-c14262bcc589 61 fields · synced May 19, 2026
- EUDAMED cbbde023-8e3a-4ad4-a58f-de1d73cd9488 61 fields · synced Jul 10, 2026
- EUDAMED 2279dcf4-43c2-409d-8b44-70dcb4552c86 61 fields · synced Jul 19, 2026
- EUDAMED 7516f61e-dc66-4cb7-8ba1-4064449523e3 61 fields · synced Aug 2, 2026
- EUDAMED 84d9c7b3-8c9f-45f7-967b-7613005a7756 61 fields · synced Aug 2, 2026