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Drill Bits

by Jeil Medical Corporation 41 variants

Ref 112-MD-STOP12, 112-MX-511, 112-MC-STOP12, 112-MD-STOP08, 112-MD-STOP10, 122-MC-301

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000894099075K Basic UDI-DI Date21 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08806390850612 UDI-DI Date28 Nov 2018ListedStatusListed 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  • Withdrawn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
Drill Bits EUDAMED
Drill bit GUDID
Generic Name
Fluted surgical drill bit, reusable
Model / Reference
112-MD-STOP12, 112-MX-511, 112-MC-STOP12, 112-MD-STOP08, 112-MD-STOP10, 122-MC-301
Primary DI / UDI-DI
08806390850612, 08806390851930, 08800089422357, 08806390869836, 08806390862349, 08809265158011
Basic UDI-DI
88000894099075K, B-08806390851930, B-08809265158011, B-08806390862349, B-08800089422357, B-08806390869836, B-08806390850612
FDA Product Code
HTW
EMDN Code
Z12130503 Orthopaedic surgical drills
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Spain
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 IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
KR-MF-000008788
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Jeil Medical Corporation

See all devices from Jeil Medical Corporation →

Properties

  • Reusable
  • 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