← Back to catalogue
FlowEase [Subcutaneous] Infusion Set, 12mm
EUDAMEDClass IIb (EU MDR)
Ref EU1M3012
Identity
- Trade Name
- FlowEase [Subcutaneous] Infusion Set, 12mm EUDAMED
- Device Name
- FlowEase EUDAMED
- Model / Reference
- EU1M3012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850025688512 EUDAMED
- Basic UDI-DI
- 0850025688FlowEaseB7 EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
FlowEase [Subcutaneous] Infusion Set, 12mm by Takeda Pharmaceuticals U.S.A., Inc. — Class IIb — 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 | 0850025688FlowEaseB7 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Takeda Pharmaceuticals U.S.A., Inc.
- EUDAMED SRN
- US-MF-000014749
- Authorised Representative
- Takeda Pharmaceuticals International AG Ireland Branch IE-AR-000037116
Sources (1)
- EUDAMED 980262f8-50f8-4ba2-ac1a-b18c1f99f68f 61 fields · synced Jun 20, 2026