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Kaydee Sterile Disposable Skin Stapler

by Xi'an Kaydee Medical Appliances Co., Ltd. EUDAMEDGUDID

Active European Union

Ref SSK-30R

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6947084900014AA Basic UDI-DIDate21 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06947084922306 UDI-DIDate22 Nov 2022ListedStatusListed 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  • Withdrawn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

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Kaydee Sterile Disposable Skin Stapler EUDAMED
Kaydee GUDID
Generic Name
Skin stapler/staple, non-bioabsorbable
Device Name
Sterile Disposable Skin Stapler
Model / Reference
SSK-30R
Primary DI / UDI-DI
06947084922306
Basic UDI-DI
6947084900014AA
FDA Product Code
QQS
EMDN Code
H02010101 Skin staplers, single-use
GMDN Term
Skin stapler/staple, non-bioabsorbable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4740
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000021140
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Xi'an Kaydee Medical Appliances Co., Ltd

See all devices from Xi'an Kaydee Medical Appliances Co., Ltd →

Properties

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

Other properties (19)

  • 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
  • Manufacturing Date: No