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NumenFR

FDA UDI

Class II (US FDA UDI)

by MicroPort NeuroTech (Shanghai) Co., Ltd.

Identity

Trade Name
NumenFR FDA UDI
Generic Name
Vascular implant detacher, electronic, single-use FDA UDI
Device Name
The MicroPort NeuroTech NumenFR Detachment System is a sterile, handheld, single-patient use device designed for use with MicroPort NeuroTech Numen Coil Embolization System. The device is operated by two pre-loaded batteries. FDA UDI
Model / Reference
E101 FDA UDI
Description
The MicroPort NeuroTech NumenFR Detachment System is a sterile, handheld, single-patient use device designed for use with MicroPort NeuroTech Numen Coil Embolization System. The device is operated by two pre-loaded batteries. FDA UDI

Identifiers

Primary DI / UDI-DI
06958698011690 FDA UDI
510(k) Number
K203625 FDA UDI
K232955 FDA UDI
K242154 FDA UDI
FDA Product Code
HCG FDA UDI
KRD FDA UDI
GMDN Term
Vascular implant detacher, electronic, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5950 FDA UDI
870.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Vascular implant detacher, electronic, single-use

NumenFR by MicroPort NeuroTech (Shanghai) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular implant detacher, electronic, single-use.

Cleared under the same submission

K203625 also covers:

K232955 also covers:

K242154 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MicroPort NeuroTech (Shanghai) Co., Ltd.

Sources (1)

  • FDA UDI 7043dae5-2760-4475-9fd3-f193582fcd45 34 fields · synced Jun 8, 2026