Identity
- Trade Name
- Advance Serenity™ 18 EUDAMEDFDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Advance Serenity™ 18 EUDAMED018 Advance Serenity 9x80, 135cm FDA UDI
- Model / Reference
- SER18-135-90-80 EUDAMEDFDA UDI
- Description
- 018 Advance Serenity 9x80, 135cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391525787343 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391525787343 EUDAMED
- 510(k) Number
- K180007 FDA UDI
- FDA Product Code
- LIT FDA UDI
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Ireland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Balloon Diameter — 9.0 Millimeter FDA UDIBalloon Length — 80 Millimeter FDA UDICatheter Working Length — 135 Centimeter FDA UDI
Category: Peripheral angioplasty balloon catheter, basic
Advance Serenity™ 18 by Creagh Medical Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
- Advocate™ — Merit Medical Systems, Inc. · Class II
- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391525787343 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Creagh Medical Ltd
- EUDAMED SRN
- IE-MF-000005164
Sources (2)
- EUDAMED 1052b765-2a7e-49e1-b2ff-a3cb4fc252f7 61 fields · synced Jul 25, 2026
- FDA UDI c728afcb-1c30-402c-b796-7030568ddb52 35 fields · synced May 29, 2026