InnoFine

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 10631Model DEK series, DTK series, NGB-xxx-DK series

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

Identity

Trade Name: Endocavity biopsy kit EUDAMED
InnoFine FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Device Name: Disposable Needle Guides Kit EUDAMED
Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with |Mindray| 65EC10(EA,EB,EC,ED,HA), 65EB10EA, 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); |Wisonic| EV10-4, EV11-3-H; |Landwind| EC4-9; |Samsung| EC4-9IS, EC4-9ES, ER4-9ES; |GE Healthcare| IC5-9; |VINNO| G4-9E, X4-9E, F4-9E; |Zoncare| 6E1CD ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands. FDA UDI
Model / Reference: DEK series, DTK series, NGB-xxx-DK series EUDAMED
10631 EUDAMED
DEK-001 FDA UDI
Description: Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with |Mindray| 65EC10(EA,EB,EC,ED,HA), 65EB10EA, 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); |Wisonic| EV10-4, EV11-3-H; |Landwind| EC4-9; |Samsung| EC4-9IS, EC4-9ES, ER4-9ES; |GE Healthcare| IC5-9; |VINNO| G4-9E, X4-9E, F4-9E; |Zoncare| 6E1CD ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands. FDA UDI

Identifiers

Catalog Number: 10631 FDA UDI
Primary DI / UDI-DI: 06971554726316 EUDAMEDFDA UDI
Basic UDI-DI: 69715547205X2 EUDAMED
FDA Product Code: OIJ FDA UDI
EMDN Code: A018002 NEEDLE GUIDES EUDAMED
GMDN Term: Needle guide, single-use FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

Yes

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Needle guide, single-use

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

Similar devices

Also classified as Needle guide, single-use.

Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
Sterile transrectal needle guide with sheath — Exact Imaging · Class II
Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
Coaxial needle — Möller Medical GmbH · Class II
Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Coaxial needle — Möller Medical GmbH · Class II
Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Verza Guidance System Master Carton — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
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 (2)

FDA UDI ef170432-432c-46fe-b634-c02ea089f2e3 36 fields · synced Jul 11, 2026
EUDAMED f4efbfc9-facb-497d-a7e6-7beaa65e7761 61 fields · synced Jul 11, 2026