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First Aid Kit

by Yiwu Ori-Power Medtech Co., Ltd. 5 variants

Ref HRN1112

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 Number697468605FAK1020M9 Basic UDI-DI 06974686051004UDI-DIDate7 Dec 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06974686051004 UDI-DI Date16 Sep 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  • Withdrawn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
First Aid Kit EUDAMED
OP - First aid series GUDID
Generic Name
Surgical scrub sponge
Model / Reference
HRN1112 EUDAMED
OP202 GUDID
Primary DI / UDI-DI
06974686051004
Basic UDI-DI
697468605FAK1020M9
FDA Product Code
OHO
EMDN Code
M9099 General and specialist medical devices – other (suture patches see h900102)
GMDN Term
Surgical scrub sponge
Device Class
Class I
Regulation Number
878.4014
Medical Purpose
Provide first aid
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
HRN1112
GUDID
OP202
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
CN-PR-000039035

Other devices from Yiwu Ori-Power Medtech Co., Ltd.

See all devices from Yiwu Ori-Power Medtech Co., Ltd. →

Properties

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

Other properties (7)

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