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Subtilis-Lambotte Flachmeissel gerade 10 mm, 25 cm

by Accuratus AG

Ref 35.54.61Model 35.57.71-S

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

CE MDD

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/MDD EUDAMED NumberB-07640229291143 Basic UDI-DI 07640229291143UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640229291143 UDI-DI Date30 Jul 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Subtilis-Lambotte Flachmeissel gerade 10 mm, 25 cm EUDAMED
Subtilis Osteotome Lambotte straight 10 mm 25 cm GUDID
Generic Name
Orthopaedic osteotome
Device Name
Subtilis Osteotome Lambotte curved 20 mm 25 cm special sharpening
Model / Reference
35.54.61, 35.57.71-S
Primary DI / UDI-DI
07640229291143
Basic UDI-DI
B-07640229291143, 0764022929PG0135RX
Direct Marketing DI
07640229291143
FDA Product Code
HWM
EMDN Code
L0399 General surgery instruments, reusable - other
GMDN Term
Orthopaedic osteotome
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
CH-MF-000018336
Authorised representative
Accuratus UG DE-AR-000026461

Other devices from Accuratus AG

See all devices from Accuratus AG →

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No