Identity
- Trade Name
- CRE™ EUDAMEDCRE Fixed Wire FDA UDI
- Generic Name
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
- Device Name
- CRE™ Fixed Wire Balloon Dilatation Catheter EUDAMEDEsophageal Balloon Dilatation Catheter FDA UDI
- Model / Reference
- M00558340 EUDAMEDFDA UDI
- Description
- Esophageal Balloon Dilatation Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729201991 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000472ND EUDAMED
- FDA Product Code
- KNQ FDA UDI
- EMDN Code
- G0301010101 OESOPHAGEAL BALLOON CATHETERS, LOW PRESSURE EUDAMED
- GMDN Term
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5365 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
Cre™ 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 | 01915060000000000000472ND | 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 c84c9cd0-648c-437e-a11d-c553081d2567 61 fields · synced Oct 5, 2026
- FDA UDI 71d1982f-74a9-46a5-b9a1-d48cca14170c 34 fields · synced May 30, 2026