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ERPeak ER20190829-03

by CooperSurgical, Inc.

Ref ER20190829-03

ERPeak ER20190829-03 is a device classified as Class A in the EU and Class I in the US made by CooperSurgical, Inc., registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0888937TD125ZQ) and listed in FDA GUDID since 10 Apr 2024 (UDI-DI 60888937027718), active as of 23 Oct 2026.

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

CE IVDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0888937TD125ZQ Basic UDI-DI 60888937027718UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number60888937027718 UDI-DI Date10 Apr 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0888937TD125ZQ registered 28 May 2026 Active
  • FDA GUDID UDI-DI 60888937027718 listed 10 Apr 2024 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 60888937027718
  2. Registered EUDAMED 0888937TD125ZQ

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  • Withdrawn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

Trade name
ERPeak
Generic name
General specimen container IVD, additive/medium
Device name
Endometrial Biopsy Kit
Model / reference
ER20190829-03
Primary DI / UDI-DI
60888937027718 EUDAMED
60888937027183 GUDID
Basic UDI-DI
0888937TD125ZQ
FDA product code
NNK
EMDN code
W05020199 Samples transport, containers - other
GMDN term
General specimen container IVD, additive/medium
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.3250
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
60888937027718
GUDID
60888937027183
Device classEUDAMED
Class A
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 60888937027718; FDA GUDID lists 60888937027183), so their flags are not compared. Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: General specimen container IVD, additive/medium

Similar devices in this category

Other devices filed under SAMPLES TRANSPORT, CONTAINERS - OTHER.

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Single use
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)