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Stryker 48970062

by Avalign Technologies Inc.

Part of a family of 106 devices: see the family page

Ref 48970062

Stryker 48970062 is a Class I device made by Avalign Technologies Inc., registered in EUDAMED on 14 Nov 2025 (Basic UDI-DI 0190776CUTBM) and listed in FDA GUDID since 15 Jan 2020 (UDI-DI 00190776141004), active as of 8 Nov 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190776CUTBM Basic UDI-DI 00190776141004UDI-DIDate14 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190776141004 UDI-DI Date15 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0190776CUTBM registered 14 Nov 2025 Active
  • FDA GUDID UDI-DI 00190776141004 listed 15 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00190776141004
  2. Registered EUDAMED 0190776CUTBM

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  • Withdrawn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
Stryker
Generic name
Scalpel handle, reusable
Device name
Fistula Scissors
Model / reference
48970062
Primary DI / UDI-DI
00190776141004
Basic UDI-DI
0190776CUTBM
Direct marketing DI
00190776141004
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 registration type
Standard device
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under HANDLES FOR SCALPELS, REUSABLE.

Other devices from Avalign Technologies Inc.

See all devices from Avalign Technologies Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)