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InnoFine

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 10523

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

Identity

Trade Name
InnoFine EUDAMEDFDA UDI
Generic Name
Needle guide, single-use FDA UDI
Device Name
Disposable Needle Guides EUDAMED
Disposable Needle Guides for use with Philips C10-4ec Ultrasound Transducers FDA UDI
Model / Reference
10523 EUDAMED
DE-023 FDA UDI
Description
Disposable Needle Guides for use with Philips C10-4ec Ultrasound Transducers FDA UDI

Identifiers

Catalog Number
10523 FDA UDI
Primary DI / UDI-DI
06971554725234 EUDAMEDFDA UDI
Basic UDI-DI
69715547203WW 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

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
EUDAMED SRN
CN-MF-000014096
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 935c1966-c702-4759-9164-413c793b677d 61 fields · synced Jun 9, 2026
  • FDA UDI a858725e-6a7c-4f9c-8755-5cea66e1dc3f 36 fields · synced May 30, 2026