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KOMET Surgical Saw Blade KM3.412..K2

by Gebr. Brasseler GmbH & Co. KG

Ref KM3.412.K2

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E226533018SQX Basic UDI-DI 14053613275238UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14053613275238 UDI-DI Date1 Feb 2023ListedStatusListed 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  • Withdrawn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
KOMET Surgical Saw Blade
Generic Name
Surgical saw blade, sagittal, reusable
Device Name
Saw blades for bone
Model / Ref / Catalog
KM3.412.K2 EUDAMED
KM3.412..K2 GUDID
KM3.412. GUDID
Primary DI / UDI-DI
14053613275238
Basic UDI-DI
++E226533018SQX
Direct Marketing DI
04053613275231
FDA Product Code
GFA
EMDN Code
L090999 Orthopaedic surgery cutting instruments, reusable - other
GMDN Term
Surgical saw blade, sagittal, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4820
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
KM3.412.K2
GUDID
KM3.412..K2
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Surgical saw blade, sagittal, reusable

Other devices from Gebr. Brasseler GmbH & Co. KG

See all devices from Gebr. Brasseler GmbH & Co. KG →

Properties

  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No