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SCANLAN® TIP-GUARD™ instrument protectors

by Scanlan International Inc. 40 variants

Ref 1001-400

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 Number08461590TF21L5 Basic UDI-DI 00846159002133UDI-DIDate29 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00846159002133 UDI-DI Date13 Jul 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  • Withdrawn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
Scanlan® TIP-GUARD™ instrument protectors - Vented
Generic Name
Surgical instrument guard, reusable
Model / Ref / Catalog
1001-400
Primary DI / UDI-DI
00846159002133
Basic UDI-DI
08461590TF21L5
FDA Product Code
FWZ
EMDN Code
L80 Surgical instruments, reusable - various accessories
GMDN Term
Surgical instrument guard, reusable
Device Class
Class I
Regulation Number
878.4950
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000010251
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from Scanlan International Inc

See all devices from Scanlan International Inc →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

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