Identity
- Trade Name
- JADE PTA (JADE 18 OTW) EUDAMED
- Device Name
- JADE PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 597002035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934955912689 EUDAMED
- Basic UDI-DI
- B-06934955912689 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Jade Pta (jade 18 Otw) by OrbusNeich Medical (Shenzhen) Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934955912689 | Class IIa | Active |
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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 (1)
- EUDAMED 1a76aa46-13a3-4788-95ed-f4b87604d617 61 fields · synced May 29, 2026