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InnoFine

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 10095Ref JEM-001Model JEM-001, JEM-002, …… , JEM-099, JEM-100

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

Identity

Trade Name
InnoFine EUDAMEDFDA UDI
Reusable Needle Guides EUDAMED
Generic Name
Needle guide, reusable FDA UDI
Device Name
Reusable Needle Guides EUDAMED
Reusable Needle Guides for use with Philips C9-5ec, C9-5 ICT; SonoSite C8X C8e Ultrasound Transducers FDA UDI
Model / Reference
10095 EUDAMED
JEM-001 EUDAMEDFDA UDI
JEM-001, JEM-002, …… , JEM-099, JEM-100 EUDAMED
Description
Reusable Needle Guides for use with Philips C9-5ec, C9-5 ICT; SonoSite C8X C8e Ultrasound Transducers FDA UDI

Identifiers

Primary DI / UDI-DI
06971554720956 EUDAMEDFDA UDI
Basic UDI-DI
69715547201WS EUDAMED
Direct Marketing DI
06971554720956 EUDAMED
FDA Product Code
OIJ FDA UDI
EMDN Code
A018002 NEEDLE GUIDES EUDAMED
GMDN Term
Needle guide, reusable FDA UDI

Classification

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

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization 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 (3)

  • EUDAMED 2376460a-db45-442c-873f-4c4614dff6cc 61 fields · synced Jun 18, 2026
  • FDA UDI efb402e3-e2b5-4e35-b82d-bc9be33b6990 33 fields · synced May 30, 2026
  • EUDAMED 966a98b3-1687-40ef-b178-e590dd2a7844 61 fields · synced Jun 18, 2026