Ultraverse
by Bard Peripheral Vascular, Inc. 542 variants
Part of a family of 841 devices: see the family page
Ref U81003H25
Ultraverse (U81003H25) is a Class IIa device made by Bard Peripheral Vascular, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 0801741OVDRDUTB5M), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0801741OVDRDUTB5M 00801741164477 | Date20 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 0801741OVDRDUTB5M
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Ultraverse™ 014 & 018 PTA Balloon Dilatation Catheter
- Model / reference
- U81003H25
- Primary DI / UDI-DI
- 00801741164477
- Basic UDI-DI
- 0801741OVDRDUTB5M
- EMDN code
- C010402020101 PTA balloon dilatation catheters
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000017556
- Authorised representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Similar devices in this category
Other devices filed under PTA BALLOON DILATATION CATHETERS.
- Advance® 35LP PTA5-35-80-7-12.0 by COOK INCORPORATED
- SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter 48010010P by Cordis US Corp.
- Scoreflex PTA BL650-154C by OrbusNeich Medical (Shenzhen) Co.,Ltd
- SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter 48006020N by Cordis US Corp.
- Advance® 18LP PTA4-18-80-10-10 by COOK INCORPORATED
- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-4040 by Spectranetics Corporation
- CRISTAL BALLOON angioplasty catheter CBV18X45/110 by Balt extrusion SAS
- 3,0 X 220 mm VeniFlow 0.014” PTA Balloon Dilatation Catheter (80 cm) VFL14300220-80 by ALFATIP KİMYA KOZMETİK TIBBİ MALZ. SAN. VE TİC. LTD. ŞTİ.
- JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW 5925-240-32 by OrbusNeich Medical (ShenZhen) Co., Ltd.
- JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW 5940-060-32 by OrbusNeich Medical (ShenZhen) Co., Ltd.