JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 5955-015-12

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Identity

Trade Name: JADE PLUS EUDAMED
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: JADE PLUS Balloon Dilatation Catheter EUDAMED
Percutaneous Transluminal Angioplasty Balloon Catheter FDA UDI
Model / Reference: 5955-015-12 EUDAMEDFDA UDI
Description: Percutaneous Transluminal Angioplasty Balloon Catheter FDA UDI

Identifiers

Catalog Number: 5955-015-12 FDA UDI
Primary DI / UDI-DI: 06934955937385 EUDAMEDFDA UDI
Basic UDI-DI: 069349559582GZ EUDAMED
Direct Marketing DI: 06934955937385 EUDAMED
510(k) Number: K241025 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 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

Yes

FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW by OrbusNeich Medical (ShenZhen) Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

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
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

Cleared under the same submission

K241025 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

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: OrbusNeich Medical (ShenZhen) Co., Ltd.

Sources (2)

FDA UDI fddcde6c-45ef-4890-a51d-31901cd274fc 36 fields · synced Jun 16, 2026
EUDAMED 89706fcc-ac0c-4c6f-9a1d-7b3b479d34da 61 fields · synced Jun 16, 2026