Identity
- Trade Name
- GateWay™ EUDAMEDGateWay™ PLUS FDA UDI
- Generic Name
- Stopcock FDA UDI
- Device Name
- GateWay PLUS (PI) EUDAMEDY-Adapter FDA UDI
- Model / Reference
- M001153220 EUDAMEDFDA UDI
- Description
- Y-Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729734604 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000510MU EUDAMED
- FDA Product Code
- DTL FDA UDI
- EMDN Code
- C900102 HAEMOSTASIS ADAPTORS EUDAMED
- GMDN Term
- Stopcock FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4290 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
GateWay™ by Boston Scientific Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 01915060000000000000510MU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED 698187ec-e918-402e-be06-a409da766db1 61 fields · synced Jun 18, 2026
- FDA UDI 8832a320-2720-479e-b1b2-f73dc6e5f6c0 33 fields · synced May 30, 2026