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Revvity 226 Sample Collection Device

by Revvity Health Sciences, Inc . - SC United States EUDAMEDGUDID

Ref GR226XXXX

Product code PJCEMDN W0501010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081258902GR22624 Basic UDI-DIDate5 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number20812589020010 UDI-DIDate29 Aug 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

3 recalls · FDA

    • Terminated Z-2264-2020 FDA Class III initiated 19 Dec 2017

    PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.

    • Terminated Z-2756-2017 FDA Class III initiated 31 May 2017

    PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.

    • Terminated Z-0030-2014 FDA Class II initiated 5 Sep 2013 via K121864, on the same 510(k)

    Some devices may be contaminated on the back side of the device with glue in the blood application area.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Revvity 226 Sample Collection Device EUDAMED
Revvity 226 GUDID
Generic Name
Dried blood spot collection card IVD
Model / Reference
GR226XXXX EUDAMED
Newborn Screening Card GUDID
Primary DI / UDI-DI
20812589020010
Basic UDI-DI
081258902GR22624
510(k) Number
FDA Product Code
PJC
EMDN Code
W0501010199 Venous or arterious blood collection devices - other
GMDN Term
Dried blood spot collection card IVD
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
862.1675
Market of Registration
Finland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
GR226XXXX
GUDID
Newborn Screening Card
Device ClassEUDAMED
Class A
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000022419
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Revvity Health Sciences, Inc . - SC

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED c71cfce7-d9dd-423f-a390-25b1fe170eca 61 fields · synced 22 Oct 2026
  • FDA UDI a68cce97-a9d3-431e-aa67-28a7305bde87 33 fields · synced 30 May 2026