ABC Dilatation Balloon Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ABC Dilatation Balloon Catheter FDA UDI
- Generic Name
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
- Device Name
- Fixed Wire Balloon EUDAMEDthe balloon diameter is 12mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the working length is 1800mm, multistage dilation balloon catheter FDA UDI
- Model / Reference
- FWB-12/80-6/18-S EUDAMEDFDA UDI
- Description
- the balloon diameter is 12mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the working length is 1800mm, multistage dilation balloon catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06902284523609 EUDAMED06932503524100 FDA UDI
- Basic UDI-DI
- 6902284FW45712JH 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 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
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Balloon Diameter — 12 Millimeter FDA UDIBalloon Length — 8 Centimeter FDA UDI
Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated
ABC Dilatation Balloon Catheter by Micro-Tech (Nanjing) Co., Ltd. — 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.
- FUJIFILM — FUJIFILM Corporation · Class II
- Flex-Ez Stylet Wire Balloon Dilator — HOBBS MEDICAL, INC. · Class II
- MaxForce TTS — Boston Scientific · Class II
- Lumiflex — US Endoscopy · Class II
- Quantum TTC — COOK INCORPORATED · Class II
- Disposable Progressive Pressure Dilators — TeleMed Systems · Class II
- Hercules — COOK INCORPORATED · Class I
- C2 CryoBalloon Swipe Catheter, Standard — C2 Therapeutics, Inc. · 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
- Micro-Tech (Nanjing) Co., Ltd.
Sources (2)
- FDA UDI fdea3a67-1af4-4297-96fe-e1d043880696 35 fields · synced Oct 8, 2026
- EUDAMED cd444334-d0a7-4ee4-8949-165071170a1c 61 fields · synced Oct 8, 2026