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Sharps Management

by GRI Medical & Electronic Technology Co., Ltd. 58 variants

Ref 10-519001

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69319181F018L4 Basic UDI-DI 16931918180489UDI-DIDate23 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number16931918180489 UDI-DI Date27 Feb 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
ArcRoyal
Generic Name
Sharp surgical instrument counting tray/pad, single-use
Device Name
Sharps Management
Model / Reference
10-519001 EUDAMED
Model 10-519001 GUDID
Description
Yellow Needle Counter, Foam Block/Magnet, Blade Remover Feature, 20CT, 40CP_Non-sterilize_100ea/cs
Primary DI / UDI-DI
16931918180489
Basic UDI-DI
69319181F018L4
FDA Product Code
GAB
EMDN Code
A018005 Needle counting containers
GMDN Term
Sharp surgical instrument counting tray/pad, single-use
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
10-519001
GUDID
Model 10-519001

Manufacturer details

EUDAMED SRN
CN-MF-000004203
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from GRI Medical & Electronic Technology Co., Ltd.

See all devices from GRI Medical & Electronic Technology Co., Ltd. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Implantable: No
  • Reusable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No