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BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit

by Synthes GmbH 2 variants

Ref DK-200CModel BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7611819a00637K5 Basic UDI-DI 00810633022085UDI-DIDate30 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810633022085 UDI-DI Date24 Mar 2020ListedStatusListed 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  • Withdrawn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

Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use
Device Name
BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit
Model / Reference
BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit, DK-200C
Primary DI / UDI-DI
00810633022085
Basic UDI-DI
7611819a00637K5
FDA Product Code
KDD
EMDN Code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CH-MF-000013345
Authorised representative
DePuy Ireland UC IE-AR-000009328

Related devices

Category: Orthopaedic guidewire, reusable

Other devices from Synthes GmbH

See all devices from Synthes GmbH →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No