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Dental Instrument

by Cowellmedi Co., Ltd. 465 variants

Ref 2SMLA45

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08800016110487 Basic UDI-DI 08800016110487UDI-DIDate14 Oct 2025RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08800016110487 Basic UDI-DI 08800016110487UDI-DIDate14 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08800016110487 UDI-DI Date7 Aug 2024ListedStatusListed GUDID: 1 of 2 UDI-DIs 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  • Withdrawn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, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Dental Instrument EUDAMED
Multi Digital Analog EUDAMED
Dental Implants Accesseories-Reusable GUDID
Generic Name
Dental implant abutment analog, laboratory
Device Name
COWELL® Reusable Surgical Instrument
Model / Reference
2SMLA45
Primary DI / UDI-DI
08800016110487, 08800016111118
Basic UDI-DI
B-08800016110487, 880947172M01D04U08M4
FDA Product Code
NDP
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Dental implant abutment analog, laboratory
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution (UDI-DI 08800016111118)
In Commercial Distribution (UDI-DI 08800016110487)

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

  • Reusable YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: 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