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Procedure Pack

by GRI Medical & Electronic Technology Co., Ltd.

Ref 86-09208-SModel ORT-01

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 linked in EUDAMED

A group certificate may exist

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 Number69319181F080L9 Basic UDI-DI 16931918134482UDI-DIDate12 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number16931918134482 UDI-DI Date23 Nov 2022ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
Alleset
Generic Name
General surgical procedure kit, non-medicated, single-use
Device Name
Procedure Pack
Model / Reference
ORT-01, 86-09208-S
Primary DI / UDI-DI
16931918134482
Basic UDI-DI
69319181F080L9
FDA Product Code
LRO
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
GMDN Term
General surgical procedure kit, non-medicated, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4370
Medical Purpose
The indications for use of Procedure packs will be determined by the physician based upon the specific type of procedure and products required to perform the procedure.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-PR-000013744

Related devices

Category: Ophthalmic surgical procedure kit, non-medicated, single-use

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

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

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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