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InnoFine JEM-070

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

Ref JEM-070Model JEM-001, JEM-002, …… , JEM-099, JEM-100

InnoFine JEM-070 is a device classified as Class I in the EU and Class II in the US made by JingFang Precision Medical Device(Shenzhen) Co., Ltd., registered in EUDAMED on 28 Apr 2026 (Basic UDI-DI 69715547201WS) and listed in FDA GUDID since 8 Feb 2025 (UDI-DI 06971554726705), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69715547201WS Basic UDI-DI 06971554726705UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971554726705 UDI-DI Date8 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69715547201WS registered 28 Apr 2026 Active
  • FDA GUDID UDI-DI 06971554726705 listed 8 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06971554726705
  2. Registered EUDAMED 69715547201WS

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Reusable Needle Guides EUDAMED
InnoFine GUDID
Generic name
Needle guide, reusable
Model / reference
JEM-070, JEM-001, JEM-002, ……, JEM-099, JEM-100
Primary DI / UDI-DI
06971554726705
Basic UDI-DI
69715547201WS
Direct marketing DI
06971554726705
FDA product code
OIJ
EMDN code
A018002 Needle guides
GMDN term
Needle guide, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1560
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Needle guide, reusable

Similar devices in this category

Other devices filed under NEEDLE GUIDES.

Other devices from JingFang Precision Medical Device(Shenzhen) Co., Ltd.

See all devices from JingFang Precision Medical Device(Shenzhen) Co., Ltd. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)