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Isolation Gown

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

Active European Union

Ref 60-1003

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69319181F046L9 Basic UDI-DIDate16 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number16931918139418 UDI-DIDate27 Feb 2021ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Alleset
Generic Name
Isolation gown, single-use
Device Name
Isolation Gown
Model / Reference
60-1003 EUDAMED
Model 60-1003 GUDID
Primary DI / UDI-DI
16931918139418
Basic UDI-DI
69319181F046L9
Unit of Use DI
06931918139411
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
60-1003
GUDID
Model 60-1003

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