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ScheBo Extraction Buffer

by ScheBo Biotech AG

Ref 02

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 Number4260152080204C Basic UDI-DI 04260152080206UDI-DIDate23 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number04260152080206 UDI-DI Date30 Aug 2020ListedStatusListed 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  • Withdrawn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
Clinical specimen extraction buffer IVD
Model / Ref / Catalog
02, 5x
Primary DI / UDI-DI
04260152080206
Basic UDI-DI
4260152080204C
Direct Marketing DI
04260152080206
FDA Product Code
JCC
EMDN Code
W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
GMDN Term
Clinical specimen extraction buffer IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.4010
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
02
GUDID
5x
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000024072

Other devices from ScheBo Biotech AG

Properties

  • Reagent
  • Professional Testing
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No