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
- 5825-240-32 EUDAMEDFDA UDI
- Description
- Percutaneous Transluminal Angioplasty Balloon Catheter FDA UDI
Identifiers
- Catalog Number
- 5825-240-32 FDA UDI
- Primary DI / UDI-DI
- 06934955932120 EUDAMEDFDA UDI
- Basic UDI-DI
- 069349559582GZ EUDAMED
- Direct Marketing DI
- 06934955932120 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Category: Peripheral angioplasty balloon catheter, basic
A comprehensive medical device directory showcasing the JADE PLUS Balloon Dilatation Catheter.
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 b8800dea-fecc-4e45-95d2-7e46edde0007 61 fields · synced Jun 26, 2026
- FDA UDI 89b99dca-606a-43fd-bab7-30c45679849e 36 fields · synced May 27, 2026