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Zbt-Esr

by Sterile Safequip and Chemicals LTD

Ref 212406Model ZBT-ESR DT10

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

CE IVDR

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/IVDR EUDAMED Number0860011967721.ZBT10SF Basic UDI-DI 00860011967736UDI-DIDate1 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00860011967736 UDI-DI Date9 Jul 2024ListedStatusListed 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  • Withdrawn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/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Erthrocyte sedimentation rate (ESR) analyser IVD
Device Name
Erythrocyte Sedimentation Rate Analyzer
Model / Ref / Catalog
ZBT-ESR DT10 EUDAMED
212406 EUDAMED
21.ZBT10 GUDID
ZBT10 GUDID
Primary DI / UDI-DI
00860011967736
Basic UDI-DI
0860011967721.ZBT10SF
Direct Marketing DI
00860011967736
FDA Product Code
GKB
EMDN Code
W02029001 Erythrocyte sedimentation rate devices
GMDN Term
Erthrocyte sedimentation rate (ESR) analyser IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.5800
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ZBT-ESR DT10
212406
GUDID
21.ZBT10
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
IN-MF-000046714
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties

  • Surgical Instrument
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No