Identity
- Trade Name
- JADE PLUS EUDAMEDJADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- JADE PLUS Balloon Dilatation Catheter EUDAMEDPercutaneous Transluminal Angioplasty Balloon Catheter FDA UDI
- Model / Reference
- 5835-040-32 EUDAMEDFDA UDI
- Description
- Percutaneous Transluminal Angioplasty Balloon Catheter FDA UDI
Identifiers
- Catalog Number
- 5835-040-32 FDA UDI
- Primary DI / UDI-DI
- 06934955932274 EUDAMEDFDA UDI
- Basic UDI-DI
- 069349559582GZ EUDAMED
- Direct Marketing DI
- 06934955932274 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 EUDAMEDClass 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Peripheral angioplasty balloon catheter, basic
Jade Plus by OrbusNeich Medical (Shenzhen) Co., Ltd. — Class IIa — MDR, 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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 069349559582GZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- OrbusNeich Medical (Shenzhen) Co., Ltd
- EUDAMED SRN
- CN-MF-000011345
- Authorised Representative
- Quality First International OÜ EE-AR-000004308
Sources (2)
- EUDAMED 0d1e2726-8251-4f9f-a317-e76359a4ce79 61 fields · synced May 31, 2026
- FDA UDI 60d235dc-eca0-4b07-a48c-c428b266273e 36 fields · synced May 29, 2026