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First Aid Kit

by Yiwu Ori-Power Medtech Co., Ltd. 472 variants

Ref ENFAK22809701Model 28097

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697468605FAK2280974Q Basic UDI-DI 06942509210204UDI-DIDate18 Aug 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
28097, ENFAK22809701
Primary DI / UDI-DI
06942509210204
Basic UDI-DI
697468605FAK2280974Q
EMDN Code
M9099 General and specialist medical devices – other (suture patches see h900102)
Device Class
Class I
Medical Purpose
Content list： 1.adhesive plaster 22mm (7/8") 10 2.adhesive plaster 10x45mm（1/4"x4"） 5 3.adhesive plaster 40x10mm (3/8"x1-1/2") 20 4.adhesive plaster 76x19mm (3"x3/4") 30 5.triangular bandage 96x96x136cm 1 6.Swab 7CM‚10pcs 1 7.sterile gauze swab 5x5cm 4 8.Dressing 40x60cm 1 9.ice pack 100g 1 10.alcohol prep pad 3x6cm 10 11.emergency blanket 130x210 Double Silver 1 12.cleansing wipe 20x12cm 8 13.elastic gauze bandage 8cmx4m 1 14.Scissors 9cm 1 15.Whistle 4.6cm 1 16.Gloves L，2pcs/bag 1 17.Tourniquet 2.5x45cm 1 18.non-woven tape 1.25cmx5Y 1 19.plastic forceps 12.5cm 1 20.Pin 3.8cm 10 21.EVA bag 21x13x5cm 1 22.Card 1 23.display box 1 24.alarm signal 1

Manufacturer details

EUDAMED SRN
CN-PR-000039035

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Properties

Other properties (1)

  • Sterile: No