Identity
- Trade Name
- CRE™ EUDAMEDCRE™ PRO FDA UDI
- Generic Name
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
- Device Name
- CRE™ PRO Wireguided Balloon Dilatation Catheter EUDAMEDEsophageal/Pyloric/Colonic/Biliary Wireguided Balloon Dilatation Catheter FDA UDI
- Model / Reference
- M00558700 EUDAMEDFDA UDI
- Description
- Esophageal/Pyloric/Colonic/Biliary Wireguided Balloon Dilatation Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729797586 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000470N9 EUDAMED
- FDA Product Code
- FGE FDA UDI
- EMDN Code
- G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER EUDAMED
- GMDN Term
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated
Cre™ Pro by Boston Scientific — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Flex-Ez Stylet Wire Balloon Dilator — HOBBS MEDICAL, INC. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Reliant(TM) Multistage Dilatation Balloon Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Rapide(TM) Multistage Dilatation Balloon Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (2)
- FDA UDI 8e84f811-c823-4cd8-b5ce-dc5f235ed0c5 34 fields · synced Oct 7, 2026
- EUDAMED 61aaa75d-9066-4d31-abc6-c761ad906946 61 fields · synced Oct 7, 2026