Skip to content

Dental Instrument

by Cowellmedi Co., Ltd. 465 variants

Ref 2SBIC45L

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800016107067 UDI-DI Date8 Aug 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberB-08800016107067 Basic UDI-DI 08800016107067UDI-DIDate21 May 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08800016107067 Basic UDI-DI 08800016107067UDI-DIDate21 May 2024RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Dental Instrument EUDAMED
Bite Impression Coping EUDAMED
Dental Implants Accesseories-Single Use GUDID
Generic Name
Dental impression tray, single-use
Device Name
COWELL® Reusable Surgical Instrument
Model / Reference
2SBIC45L
Primary DI / UDI-DI
08800016107067
Basic UDI-DI
B-08800016107067, 880947172M01D04U08M4
FDA Product Code
NDP
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Dental impression tray, single-use
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No