InnoFine

FDA UDI

Class II (US FDA UDI)

by JingFang Precision Medical Device(Shenzhen) Co., Ltd.

Identity

Trade Name: InnoFine FDA UDI
Generic Name: Needle guide, reusable FDA UDI
Device Name: Reusable Needle Guides for use with Mindray 65EC10(EA,EB,EC,ED,HA),6CV1(s,P),CB10-4(s,P,E,A),V10-4(s),V10-4B(s,P),V11-3(E,s),V11-3B(E),V11-3W(s,E),E9-3,V11-3H(E,U,s); Lanmage EC4-9(Y),EC3-11; VINNO G4-9E; Zoncare 6E1CD; Hisense E9-4B,E9-4E; Krinwave EC5(v); COMEN E3-11H; Wisonic EV10-4, EV11-3-H; Esaote E8-5; ULTRAST R10H6 Ultrasound Transducers FDA UDI
Model / Reference: JEM-028 FDA UDI
Description: Reusable Needle Guides for use with Mindray 65EC10(EA,EB,EC,ED,HA),6CV1(s,P),CB10-4(s,P,E,A),V10-4(s),V10-4B(s,P),V11-3(E,s),V11-3B(E),V11-3W(s,E),E9-3,V11-3H(E,U,s); Lanmage EC4-9(Y),EC3-11; VINNO G4-9E; Zoncare 6E1CD; Hisense E9-4B,E9-4E; Krinwave EC5(v); COMEN E3-11H; Wisonic EV10-4, EV11-3-H; Esaote E8-5; ULTRAST R10H6 Ultrasound Transducers FDA UDI

Identifiers

Primary DI / UDI-DI: 06971554720017 FDA UDI
FDA Product Code: OIJ FDA UDI
GMDN Term: Needle guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Needle guide, reusable

InnoFine by JingFang Precision Medical Device(Shenzhen) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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EV29L Non-Sterile Reusable PrecisionPoint Adapter — Exact Imaging · Class II
Endocavity Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
Gimmi — Gimmi GmbH · Class I
MP-2785-G23 — FUJIFILM Corporation · Class II

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

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Manufacturer

Manufacturer: JingFang Precision Medical Device(Shenzhen) Co., Ltd.

Sources (1)

FDA UDI 02808c45-6563-4504-a60e-a6dcfbf640b5 33 fields · synced Jun 7, 2026