Identity
- Trade Name
- NeuAngio 30F Flex EUDAMED
- Device Name
- Medical Angiography X-ray System EUDAMED
- Model / Reference
- none EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970167441821 EUDAMED
- Basic UDI-DI
- 6970167440000000000000136 EUDAMED
- EMDN Code
- Z11030102 STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
NeuAngio 30F Flex by Neusoft Medical Systems Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6970167440000000000000136 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000011819
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a1940e11-0a76-441b-9d4a-794185af62a3 61 fields · synced Aug 2, 2026