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Scalpel Handle, Round

by Avalign Technologies Inc.

Ref 03.520.022

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190776HANDLEMA Basic UDI-DI 00190776028305UDI-DIDate17 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190776028305 UDI-DI Date8 Dec 2017ListedStatusListed 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  • Withdrawn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
Depuy Synthes
Generic Name
Scalpel handle, reusable
Model / Reference
03.520.022
Primary DI / UDI-DI
00190776028305
Basic UDI-DI
0190776HANDLEMA
Direct Marketing DI
00190776028305
FDA Product Code
GDZ
EMDN Code
L010103 Handles for scalpels, reusable
GMDN Term
Scalpel handle, reusable
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Bulgaria
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000008511
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from AVALIGN TECHNOLOGIES, Inc.

See all devices from AVALIGN TECHNOLOGIES, Inc. →

Properties

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

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Manufacturing Date: No