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Dental Instrument

by Cowellmedi Co., Ltd. 465 variants

Ref 2SIH45L

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809471723690 UDI-DI Date24 May 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberB-08809471723690 Basic UDI-DI 08809471723690UDI-DIDate16 May 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08809471723690 Basic UDI-DI 08809471723690UDI-DIDate16 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  • Withdrawn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
Pick-up Impression Coping EUDAMED
INNO SLA Submerged Implant System-Impression Coping GUDID
Generic Name
Dental precision attachment simulator/analog, single-use
Device Name
2SIH45L
COWELL® Reusable Surgical Instrument
Model / Reference
2SIH45L
Primary DI / UDI-DI
08809471723690
Basic UDI-DI
B-08809471723690, 880947172M01D04U08M4
FDA Product Code
NHA
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Dental precision attachment simulator/analog, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3630
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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