Numen
by MicroPort NeuroTech (Shanghai) Co., Ltd. 438 variants
Part of a family of 399 devices: see the family page
Ref 3D1H02FNUModel 3D0820FN
Numen (3D1H02FNU) is a Class III device made by MicroPort NeuroTech (Shanghai) Co., Ltd., registered in EUDAMED on 8 Dec 2022 (Basic UDI-DI 69586980T0040TL) with CE/MDR certificate 1000323760 valid until 12 Feb 2030, active as of 25 Oct 2026.
Active
CE MDR
Valid until
12 Feb 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000323760 | Date8 Jul 2026 | StatusActive |
Official records
- EUDAMED public site 69586980T0040TL
Certificates
- 1000316127 Active
Technical documentation EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 21 May 2026
- Expires
- 12 Feb 2030
- Reason
- Change approved
- 1000323760 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 8 Jul 2026
- Expires
- 12 Feb 2030
- Reason
- Add device or group
Timeline
- Registered EUDAMED 69586980T0040TL
- Certificate issued EUDAMED 1000316127
- Certificate issued EUDAMED 1000323760
- Certificate expires EUDAMED 1000323760
- Certificate expires EUDAMED 1000316127
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Numen Coil Embolization System
- Model / reference
- 3D0820FN, 3D1H02FNU
- Primary DI / UDI-DI
- 06958698061480
- Basic UDI-DI
- 69586980T0040TL
- EMDN code
- C010402020301 Embolisation coils
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000007053
- Authorised representative
- MicroPort Medical B.V. NL-AR-000000166
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