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Isolation Gown

by GRI Medical & Electronic Technology Co., Ltd. EUDAMEDGUDID

Active European Union

Ref 60-2034, 70-1030, 60-5031, 60-2030, 60-4031, 68-480261, 60-1020, 60-2032, 60-4032, 60-4011, 60-1030, 60-4012, 60-2035, 60-2001, 60-3095, 60-4034, 60-3041, 60-1000, 60-2031, 60-4024, 60-6001, 60-1001

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number16931918179476 UDI-DIDate2 Feb 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69319181F046L9 Basic UDI-DIDate16 Jun 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Alleset
Generic Name
Isolation gown, single-use
Device Name
Isolation Gown
Model / Reference
60-2034, 70-1030, 60-5031, 60-2030, 60-4031, 68-480261, 60-1020, 60-2032, 60-4032, 60-4011, 60-1030, 60-4012, 60-2035, 60-2001, 60-3095, 60-4034, 60-3041, 60-1000, 60-2031, 60-4024, 60-6001, 60-1001
Primary DI / UDI-DI
16931918179476, 16931918185576, 16931918176451, 16931918169224, 16931918161228, 16931918125305, 16931918117492, 16931918172163, 16931918163987, 16931918133287, 16931918140766, 16931918129518, 16931918163338, 16931918131238, 16931918164151, 16931918117249, 16931918192093, 16931918133911, 16931918119403, 16931918136875, 16931918195414, 16931918193281
Basic UDI-DI
69319181F046L9
Unit of Use DI
06931918179479, 06931918185579, 06931918176454, 06931918169227, 06931918161221, 06931918125308, 06931918117495, 06931918172166, 06931918163980, 06931918133280, 06931918140769, 06931918129511, 06931918163331, 06931918131231, 06931918164154, 06931918117242, 06931918192096, 06931918133914, 06931918119406, 06931918136878, 06931918195417, 06931918193284
FDA Product Code
OEA
EMDN Code
T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
GMDN Term
Isolation gown, single-use
Device Class
Class I
Regulation Number
878.4040
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

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