Identity
- Trade Name
- JADE PLUS EUDAMEDJADE 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 EUDAMEDPercutaneous Transluminal Angioplasty Balloon Catheter FDA UDI
- Model / Reference
- 5915-150-22 EUDAMEDFDA UDI
- Description
- Percutaneous Transluminal Angioplasty Balloon Catheter FDA UDI
Identifiers
- Catalog Number
- 5915-150-22 FDA UDI
- Primary DI / UDI-DI
- 06934955937743 EUDAMEDFDA UDI
- Basic UDI-DI
- 069349559582GZ EUDAMED
- Direct Marketing DI
- 06934955937743 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
Jade Plus by OrbusNeich Medical (Shenzhen) Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 3c0faed5-156d-4c3b-9fa7-cdfe240f47d9 61 fields · synced May 30, 2026
- FDA UDI 52c4ea55-83ca-4897-93f6-d35668b7539f 36 fields · synced May 30, 2026