Identity
- Trade Name
- NumenFR EUDAMED
- Device Name
- NumenFR Detachment System EUDAMED
- Model / Reference
- E101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958698005781 EUDAMED
- Basic UDI-DI
- B-06958698005781 EUDAMED
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
NumenFR by MicroPort NeuroTech (Shanghai) 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-06958698005781 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MicroPort NeuroTech (Shanghai) Co., Ltd.
- EUDAMED SRN
- CN-MF-000007053
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED 7c996f46-ed36-4bbb-b30f-a76cb1a77583 61 fields · synced Jul 11, 2026