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First Aid Kit

by Dongyang City Yonoel Outdoor Products Co., Ltd. 4 variants

Ref FAKUN521G, FAKUN521Model UN521G, UN521

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
United StatesGUDID listing GUDID Number06977117870069 UDI-DI Date2 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697711787UN521GQN Basic UDI-DI Date9 Jun 2025RegisteredStatusActive

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  • Withdrawn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
Aidhelp
Generic Name
First aid kit, non-medicated, single-use
Device Name
First Aid Kit
Model / Reference
UN521G, FAKUN521G, UN521, FAKUN521
Primary DI / UDI-DI
06977117870069, 06977117870021
Basic UDI-DI
697711787UN521GQN, 697711787UN521PR
FDA Product Code
OHO
EMDN Code
V0501 Clinical emergency kits
GMDN Term
First aid kit, non-medicated, single-use
Device Class
Class I
Regulation Number
878.4014
Medical Purpose
A portable bag equipped with medical instruments and materials, mainly used for dealing with sudden diseases, accidental injuries or emergency medical conditions
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
CN-PR-000046992

Other devices from Dongyang City Yonoel Outdoor Products Co., Ltd.

See all devices from Dongyang City Yonoel Outdoor Products Co., Ltd. →

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing 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
  • Expiration Date: No