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Na CD100SP

by ZimVie US Corp LLC

Ref CD100SP

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

CE MDR

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 Number844868AFJ2 Basic UDI-DI 00844868042501UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868042501 UDI-DI Date5 Dec 2019ListedStatusListed GUDID: 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Countersink Drills
Generic Name
Fixture/appliance dental drill bit, single-use
Device Name
Sterile powered surgically invasive instrument
Model / Reference
CD100SP
Primary DI / UDI-DI
00844868042501
Basic UDI-DI
844868AFJ2
FDA Product Code
NDP
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
Fixture/appliance dental drill bit, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3980
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Fixture/appliance dental drill bit, single-use

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Sterile
  • Single Use
  • Reusable
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Implantable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Manufacturing Date: No