Minerva PTA Balloon Dilatation Catheter

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 803-045100-150

by BrosMed Medical Co., Ltd

Identity

Trade Name: Minerva EUDAMED
Minerva PTA Balloon Dilatation Catheter FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: Minerva PTA Balloon Dilatation Catheter EUDAMED
Minerva / Xpansion PTA Balloon Dilatation Catheter EUDAMED
Model / Reference: 803-045100-150 EUDAMED
rev 01 FDA UDI

Identifiers

Catalog Number: 803-045100-150U FDA UDI
Primary DI / UDI-DI: 06958481419092 EUDAMEDFDA UDI
Basic UDI-DI: B-06958481419092 EUDAMED
695848140013LY EUDAMED
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 EUDAMED
Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

Minerva PTA Balloon Dilatation Catheter by BrosMed Medical Co., Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

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
RapidCross — Covidien LP · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-06958481419092	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-06958481419092	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: BrosMed Medical Co., Ltd
EUDAMED SRN: CN-MF-000007501
Authorised Representative: Brosmed Medical B.V. NL-AR-000002616

Sources (3)

EUDAMED aa921c69-6284-4a09-957e-8bd713792c01 61 fields · synced Jul 18, 2026
EUDAMED cf2bd0f6-6e28-484c-8cfd-5b8656e26fc0 61 fields · synced May 18, 2026
FDA UDI 03f172f9-c1b0-429e-ac8e-21922433b918 33 fields · synced May 30, 2026