Identity
- Trade Name
- Esophageal Balloon Dilator EUDAMEDQuantum TTC FDA UDI
- Generic Name
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
- Device Name
- Non-Sterile Balloon Dilators EUDAMEDQuantum TTC Esophageal Balloon Dilator FDA UDI
- Model / Reference
- QD-20X8 EUDAMEDG31511 FDA UDI
- Description
- Quantum TTC Esophageal Balloon Dilator FDA UDI
Identifiers
- Catalog Number
- QD-20X8 FDA UDI
- Primary DI / UDI-DI
- 00827002315112 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002WCM00000000001MA EUDAMED
- FDA Product Code
- KNQ 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 I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5365 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Esophageal Balloon Dilator by Wilson-Cook Medical, Inc. — 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 | 0827002WCM00000000001MA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (2)
- EUDAMED a60840a1-a3be-400f-8388-438e9ee5a038 61 fields · synced Jun 18, 2026
- FDA UDI 82eeddff-dfc3-47eb-827c-3a191abc90b7 36 fields · synced May 30, 2026