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Surgical Drive System

by Guangdong JINME Medical Technology Co., Ltd. 3 variants

Ref E8Model ES90, ES70, E80, AE62, E8

Surgical Drive System (E8) is a device classified as Class IIa in the EU and Class II in the US made by Guangdong JINME Medical Technology Co., Ltd., registered in EUDAMED on 12 Dec 2024 (Basic UDI-DI 697111954ESXXN6), cleared under FDA 510(k) K240340 on 18 Jul 2024 and listed in FDA GUDID since 15 Jul 2025 (UDI-DI 06971119540883), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240340

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971119540883 UDI-DI Date15 Jul 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697111954ESXXN6 Basic UDI-DI 06971119540883UDI-DIDate12 Dec 2024RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK240340 Date18 Jul 2024IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697111954ESXXN6 registered 12 Dec 2024 Active
  • FDA 510(k) K240340 decided 18 Jul 2024 Active
  • FDA GUDID UDI-DI 06971119540883 listed 15 Jul 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240340
  2. Registered EUDAMED 697111954ESXXN6
  3. Listed FDA GUDID 06971119540883

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Surgical power tool system control unit, line-powered
Model / reference
ES90, ES70, E80, AE62, E8
Primary DI / UDI-DI
06971119540883
Basic UDI-DI
697111954ESXXN6
Direct marketing DI
06971119540883
510(k) Number
FDA product code
DZI, ERL
EMDN code
Q010399, Z12110101
GMDN term
Surgical power tool system control unit, line-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.4120, 874.4250
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
CN-MF-000033806
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under DENTAL TREATMENT UNITS.

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Properties

  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)