Identity
- Trade Name
- Sapphire NC 24 EUDAMED
- Device Name
- Sapphire NC 24 Coronary Dilatation Catheter EUDAMED
- Model / Reference
- 215-124-5J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934955949036 EUDAMED
- Basic UDI-DI
- B-06934955949036 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 NC 24 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-06934955949036 | 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 1d15f79b-b78c-4601-97e9-0c5b112c9e01 61 fields · synced May 29, 2026