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Dental Instrument

by Cowellmedi Co., Ltd. South Korea EUDAMEDGUDID

Ref 2SMPP55

Product code NDPEMDN P01020180

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800016100808 UDI-DIDate7 Aug 2024ListedStatusIn distribution
European UnionCE/MDR EUDAMED NumberB-08800016100808 Basic UDI-DIDate21 May 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08800016100808 Basic UDI-DIDate21 May 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Dental Instrument EUDAMED
Multi Polishing Protector EUDAMED
Dental Implants Accesseories-Reusable GUDID
Generic Name
Dental implant suprastructure, temporary, preformed, reusable
Device Name
COWELL® Reusable Surgical Instrument
Model / Reference
2SMPP55
Primary DI / UDI-DI
08800016100808
Basic UDI-DI
B-08800016100808, 880947172M01D04U08M4
FDA Product Code
NDP
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Dental implant suprastructure, temporary, preformed, reusable
Device Class
Class I
Regulation Number
872.3980
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
KR-MF-000009689
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Cowellmedi Co., Ltd

See all devices from Cowellmedi Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Implantable NoEUDAMEDYesGUDID
  • Reusable YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date
Other properties (18)
  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED bc67e4e5-b0ed-4951-83be-96d099d23e71 61 fields · synced 22 Oct 2026
  • FDA UDI 57bd955a-39d0-4641-b22f-4654693eb195 32 fields · synced 30 May 2026
  • EUDAMED 08800016100808|880947172M01D04U08M4 61 fields · synced 24 Oct 2026