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Surgical Drive System

by Guangdong JINME Medical Technology Co., Ltd.

Ref AE62, E83, E80, AE60Model ES90, ES70, E80, AE62, E8, ES90, ES70, E80, E83, AE62, AE60,E8510(k) K240340

Surgical Drive System (AE62) 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) and cleared under FDA 510(k) K240340 on 18 Jul 2024, active as of 24 Oct 2026.

Active European Union and United States

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 record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697111954ESXXN6 Basic UDI-DI Date12 Dec 2024RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK240340 Date18 Jul 2024ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697111954ESXXN6 registered 12 Dec 2024 Active
  • FDA 510(k) K240340 decided 18 Jul 2024 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K240340
  2. Registered EUDAMED 697111954ESXXN6

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / reference
ES90, ES70, E80, AE62, E8, E83, AE60
Primary DI / UDI-DI
06971119540913, 06971119540876, 06971119540081, 06971119540890
Basic UDI-DI
697111954ESXXN6
Direct marketing DI
06971119540913
06971119540876
06971119540081
06971119540890
510(k) Number
FDA product code
DZI
EMDN code
Q010399, Z12110101
Device class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 872.4120
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class IIa
510(k)
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

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

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Properties

  • Reusable
Other properties (13, all answered No)