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Saw blades for endoprosthetics single use

by Gebr. Brasseler GmbH & Co. KG 18 variants

Ref KMS0813.M50.M2

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 Number++E2265330303N Basic UDI-DI 14053613285190UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14053613285190 UDI-DI Date12 Jun 2026ListedStatusListed 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  • Withdrawn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, single-use
Device Name
Saw blades for endoprosthetics single use
Model / Ref / Catalog
KMS0813.M50.M2 EUDAMED
KMS0813.M50..M2 GUDID
KMS0813.M50. GUDID
Primary DI / UDI-DI
14053613285190
Basic UDI-DI
++E2265330303N
FDA Product Code
GFA
EMDN Code
P091305 Bone saws, single-use
GMDN Term
Surgical saw blade, sagittal, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4820
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
KMS0813.M50.M2
GUDID
KMS0813.M50..M2
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000006446

Other devices from Gebr. Brasseler GmbH & Co. KG

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: 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