Skip to content

Scalpel, Handle, Fig.3 12.5cm for blades #9-17 16-0003

by Geister Medizin Technik GmbH

Ref 16-0003

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 25 Oct 2026. What this means

Overview

The Scalpel, Handle, Fig.3 12.5cm for blades #9-17 is a reusable surgical instrument designed to be used as a handle to mount a compatible blade, providing a single-bladed cutting or dissecting capability. Made of metal (stainless steel or brass), this device is typically sterilized and manufactured after each use. As an interchangeable component within the scalpel family, it can be easily replaced and resold.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40570340000000624N7 Basic UDI-DI 04057034037690UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04057034037690 UDI-DI Date24 Jul 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  • Withdrawn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
Scalpel, Handle, Fig.3 12.5cm for blades #9-17
Generic Name
Scalpel handle, reusable
Device Name
Skalpellgriff
Model / Ref / Catalog
16-0003
Primary DI / UDI-DI
04057034037690
Basic UDI-DI
40570340000000624N7
Direct Marketing DI
04057034037690
FDA Product Code
GDZ
EMDN Code
L010103 Handles for scalpels, reusable
GMDN Term
Scalpel handle, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Scalpel handle, reusable

Other devices from Geister Medizin Technik GmbH

See all devices from Geister Medizin Technik GmbH →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

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