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EZX Blade XTB400

by Imedicom Co., Ltd.

Ref CAR-BLADE-03Model XTB400

EZX Blade XTB400 is a device classified as Class IIa in the EU and Class I in the US made by Imedicom Co., Ltd., registered in EUDAMED on 3 Oct 2026 (Basic UDI-DI B-08800038036123) and listed in FDA GUDID since 22 Nov 2019 (UDI-DI 08800038036123), active as of 24 Oct 2026.

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

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800038036123 Basic UDI-DI 08800038036123UDI-DIDate3 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800038036123 UDI-DI Date22 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800038036123 registered 3 Oct 2026 Active
  • FDA GUDID UDI-DI 08800038036123 listed 22 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800038036123
  2. Registered EUDAMED B-08800038036123

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Saw Blade EUDAMED
EZX Blade GUDID
Generic name
Surgical saw blade, sagittal, single-use
Device name
Sterile single use surgical blades
Model / reference
XTB400, CAR-BLADE-03
Primary DI / UDI-DI
08800038036123
Basic UDI-DI
B-08800038036123
FDA product code
HWE
EMDN code
Z12130585 Motorised orthopaedic surgery system instruments - consumables
GMDN term
Surgical saw blade, sagittal, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Legacy device (under a directive)
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical saw blade, sagittal, single-useSurgical saw blade, reciprocating, single-use

Similar devices in this category

Other devices filed under MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS.

Other devices from Imedicom Co., Ltd.

See all devices from Imedicom Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)