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Research and Diagnostic Systems 72001

by Research and Diagnostic Systems, Inc.

Ref 72001

Research and Diagnostic Systems 72001 is a device classified as IVD General (EU), Class II (US) made by Research and Diagnostic Systems, Inc., registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI B-10815762020343), cleared under FDA 510(k) K802265 on 12 Nov 1980 and listed in FDA GUDID since 29 Jul 2016 (UDI-DI 10815762020343), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K802265

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-10815762020343 Basic UDI-DI 10815762020343UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10815762020343 UDI-DI Date29 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK802265 Date12 Nov 1980DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10815762020343 registered 25 Jun 2026 Active
  • FDA 510(k) K802265 decided 12 Nov 1980 Active
  • FDA GUDID UDI-DI 10815762020343 listed 29 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K802265
  2. Listed FDA GUDID 10815762020343
  3. Registered EUDAMED B-10815762020343

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Cbc-7 EUDAMED
Research and Diagnostic Systems GUDID
Generic name
Full blood count IVD, control
Device name
Cbc-7B
Model / Ref / Catalog
72001
Primary DI / UDI-DI
10815762020343
Basic UDI-DI
B-10815762020343
510(k) Number
FDA product code
JPK
EMDN code
W0103010503 Multilevel blood controls
GMDN term
Full blood count IVD, control
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.8625
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 20 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

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

Related devices

Category: Full blood count IVD, control

Cleared under the same submission (K802265)

and 8 more cleared under K802265

Similar devices in this category

Other devices filed under MULTILEVEL BLOOD CONTROLS.

Other devices from Research and Diagnostic Systems, Inc.

See all devices from Research and Diagnostic Systems, Inc. →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)