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Bme Elite

by Synthes GmbH 3 variants

Ref DK-300, EL-1815S2, EL-2020S2, EL-2520S4, EL-2520S2Model BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit, BME ELITE Implant Kits

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7611819a00637K5 Basic UDI-DI Date30 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810633021958 UDI-DI Date21 May 2021ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Bme Elite EUDAMED
Elite GUDID
Generic Name
Orthopaedic bone staple, non-adjustable
Orthopaedic surgical procedure kit, non-medicated, single-use
Device Name
BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit
BME ELITE Implant Kits
Model / Ref / Catalog
BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit, DK-300, EL-1815S2, EL-2520S2, EL-2020S2, EL-2520S4, BME ELITE Implant Kits, EL1815S2, EL2520S2, DK300, EL2020S2, EL2520S4
Primary DI / UDI-DI
00810633021958, 07612334226655, 07612334226679, 00810633021699, 00810633021705
Basic UDI-DI
7611819a00637K5, 7611819a00645K4
510(k) Number
FDA Product Code
JDR, KDD
EMDN Code
Z12139099, P09120101
GMDN Term
Orthopaedic bone staple, non-adjustable
Orthopaedic surgical procedure kit, non-medicated, single-use
Device Class
Class IIa EUDAMED
Class IIb EUDAMED
Class II GUDID
Class I GUDID
Regulation Number
888.3030, 878.4800
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
Class IIb
GUDID
Class II
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
  • Implantable NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Sutures
  • CMR Substance
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • 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