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 5x60, 135cm FDA UDI
- Model / Reference
- SER18-135-50-60 EUDAMEDFDA UDI
- Description
- 018 Advance Serenity 5x60, 135cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391525787053 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391525787053 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 — 5.0 Millimeter FDA UDIBalloon Length — 60 Millimeter FDA UDICatheter Working Length — 135 Centimeter FDA UDI
Advance Serenity™ 18 by Creagh Medical Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-05391525787053 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Creagh Medical Ltd
- EUDAMED SRN
- IE-MF-000005164
Sources (2)
- EUDAMED 8660a2c2-e265-4aaa-8fad-35780d58853a 61 fields · synced Jun 1, 2026
- FDA UDI 48551b25-732e-4f7b-86bb-6131c8328092 35 fields · synced May 30, 2026