Identity
- Trade Name
- Encore™ EUDAMEDEncore™ 26 FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- Encore 26 (PI) EUDAMEDInflation Device FDA UDI
- Model / Reference
- M001151050 EUDAMEDFDA UDI
- Description
- Inflation Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729183624 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000509NB EUDAMED
- FDA Product Code
- MAV FDA UDI
- EMDN Code
- C900180 HAEMOSTASIS SYSTEMS - ACCESSORIES EUDAMED
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Encore™ by Boston Scientific Corporation — Class I — 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 | 01915060000000000000509NB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 4b9db2c6-2b0b-4da6-8d56-758127551f20 61 fields · synced Jun 19, 2026
- FDA UDI aeeec73a-9377-4d05-b9b4-ae14a3cecc02 33 fields · synced May 30, 2026