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BIOBASE R:20mL×8

by Biobase Biodustry(Shandong)Co., Ltd. 8 variants

Ref R:20mL×8(710)

BIOBASE R:20mL×8 is a device classified as IVD General (EU), Class I (US) made by Biobase Biodustry(Shandong)Co., Ltd., registered in EUDAMED on 14 May 2026 (Basic UDI-DI B-06971674860174) and listed in FDA GUDID since 8 Jul 2023 (UDI-DI 06971674860174), active as of 22 Oct 2026.

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

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-06971674860174 Basic UDI-DI 06971674860174UDI-DIDate14 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971674860174 UDI-DI Date8 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06971674860174 registered 14 May 2026 Active
  • FDA GUDID UDI-DI 06971674860174 listed 8 Jul 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 06971674860174
  2. Registered EUDAMED B-06971674860174

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Total Cholesterol (CHO) Test Kit (CHOD-PAP) EUDAMED
Biobase GUDID
Generic name
Total cholesterol lipid IVD, reagent
Model / reference
R:20mL×8(710) EUDAMED
R:20mL×8 GUDID
Primary DI / UDI-DI
06971674860174
Basic UDI-DI
B-06971674860174
FDA product code
CGO
EMDN code
W01010205 Cholesterol
GMDN term
Total cholesterol lipid IVD, reagent
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1175
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
R:20mL×8(710)
GUDID
R:20mL×8
Device classEUDAMED
Class IVD General
GUDID
Class I

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

Similar devices in this category

Other devices filed under CHOLESTEROL.

Other devices from Biobase Biodustry(Shandong) Co., Ltd.

See all devices from Biobase Biodustry(Shandong) Co., Ltd. →

Properties

  • Single use
  • Reagent
  • IVD kit
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)