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Greens

by Greens Surgicals Pvt.ltd.

Ref 1867Model 426.150510(k) K163383

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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) K163383↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number890618456INSDBSRQ Basic UDI-DI 08906184560014UDI-DIDate23 May 2024RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK163383 Date19 Apr 2017ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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)

Device Name
Drill Bit 2.5MM
Model / Reference
426.150, 1867
Primary DI / UDI-DI
08906184560014
Basic UDI-DI
890618456INSDBSRQ
510(k) Number
FDA Product Code
HRS
EMDN Code
Z12130503 Orthopaedic surgical drills
Device Class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 888.3030
EU market of registration
Germany
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
510(k)
Class II

Manufacturer details

EUDAMED SRN
IN-MF-000041517
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Greens Surgicals Pvt., Ltd.

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No