Numen

FDA UDI

Class II (US FDA UDI)

by MicroPort NeuroTech (Shanghai) Co., Ltd.

Identity

Trade Name: Numen FDA UDI
Generic Name: Neurovascular embolization coil FDA UDI
Device Name: The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. FDA UDI
Model / Reference: 3D0615FR FDA UDI
Description: The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. FDA UDI

Identifiers

Primary DI / UDI-DI: 06958698010044 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: Neurovascular embolization coil 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

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Neurovascular embolization coil

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

Similar devices

Also classified as Neurovascular embolization coil.

HydroSoft Helical — MICROVENTION INC. · Class II
Target — Stryker Corp. · Class II
Axium PrimeTM — Micro Therapeutics, Inc. · Class II
AxiumTM — Micro Therapeutics, Inc. · Class II
WEB Aneurysm Embolization System — SEQUENT MEDICAL, INC. · Class III
WEB Aneurysm Embolization System — MICROVENTION INC. · Class III
HydroFill Helical — MICROVENTION INC. · Class II
TARGET — Stryker Corp. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: MicroPort NeuroTech (Shanghai) Co., Ltd.

Sources (1)

FDA UDI 7769646b-77a1-42af-91b0-a672ef8fe1bb 34 fields · synced May 30, 2026