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Subtilis Lexer Flachmeissel gerade mit langer Klinge mit Kunststoffgriff u. Schlagplatte 25 mm 24.5 cm

by Accuratus AG

Ref 35.12.25, 35.12.10, 35.12.08Model 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07640229293857 Basic UDI-DI Date23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640229293857 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  • Withdrawn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 Lexer Flachmeissel gerade mit langer Klinge mit Kunststoffgriff u. Schlagplatte 25 mm 24.5 cm EUDAMED
Subtilis Lexer Flachmeissel gerade mit langer Klinge mit Kunststoffgriff u. Schlagplatte 10 mm 24.5 cm EUDAMED
Subtilis Lexer Flachmeissel gerade mit langer Klinge mit Kunststoffgriff u. Schlagplatte 8 mm 24.5 cm EUDAMED
Subtilis Chisel Lexer straight long blade plastic handle with impact plate 10 mm GUDID
Generic Name
Orthopaedic chisel
Device Name
Subtilis Osteotome Lambotte curved 20 mm 25 cm special sharpening
Model / Reference
35.12.25, 35.12.10, 35.12.08, 35.57.71-S
Primary DI / UDI-DI
07640229293857, 07640229290047, 07640229293314
Basic UDI-DI
B-07640229293857, B-07640229290047, B-07640229293314, 0764022929PG0135RX
Direct Marketing DI
07640229290047
07640229293314
07640229293857
FDA Product Code
FZO
EMDN Code
L0399 General surgery instruments, reusable - other
GMDN Term
Orthopaedic chisel
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