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SCANLAN® SURG-I-BAND® color coding

by Scanlan International Inc. 184 variants

Ref 1001-1112

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 Number08461590TF35LG Basic UDI-DI 00846159031829UDI-DIDate29 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00846159031829 UDI-DI Date12 Jul 2018ListedStatusListed 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  • Withdrawn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® SURG-I-BAND® Color Coding - Data Matrix
Generic Name
Surgical instrument track identification tape
Device Name
SCANLAN® SURG-I-BAND® color coding
Model / Ref / Catalog
1001-1112
Primary DI / UDI-DI
00846159031829
Basic UDI-DI
08461590TF35LG
FDA Product Code
FWZ
EMDN Code
L80 Surgical instruments, reusable - various accessories
GMDN Term
Surgical instrument track identification tape
Device Class
Class I
Regulation Number
878.4950
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: 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