Identity
- Trade Name
- Sapphire II (RX) EUDAMED
- Device Name
- Sapphire II (RX) Coronary Dilatation Catheter EUDAMED
- Model / Reference
- 234-R-1710J2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934955921636 EUDAMED
- Basic UDI-DI
- B-06934955921636 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
Sapphire II (RX) by OrbusNeich Medical (Shenzhen) Co., Ltd — Class III — 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-06934955921636 | Class III | 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 efec8860-e040-4419-bee4-a2f38ba2cacb 61 fields · synced Jun 19, 2026